The South African Health Products Regulatory Authority (SAHPRA) believes in keeping the public (consumers), industry and healthcare professionals informed on essential emerging medicine updates by publishing safety alerts, recalls, media releases and other advice related to medicines in the market.
How does SAHPRA enforce a recall?
SAHPRA enforces a recall when a product supplied in South Africa has a problem or potential problem. Enforcing a recall is the most effective way to protect the public from a potentially harmful medicine/medical product.
- Medicines recalls are usually voluntary and led by the manufacturer who acknowledges the problem and takes corrective action instead of waiting for SAHPRA to enforce its regulatory authority.
- Recall actions can vary based on the type of medical product, and the scale or scope the problem poses to public health and safety. Decisions may be to stop using a medication immediately or the medication may still be safe to continue use; healthcare professionals and patients will be duly alerted to the problem.
- In addition, after assessment of the risk to the public, SAHPRA publishes an alert through our digital platforms (via website and, social media channels), including broadcasts through TV and radio interviews.
Alerts informs public and healthcare professionals about the problem regarding the medicine/product, what to do and how to safely discard it, and also on use of unaffected batches/alternate product.
Furthermore, the recall of a particular batch or batches of a product from the market may be occasioned either following notification of:
- A track of market quality defect of a product
- Serious reports of adverse reactions not included in the package insert and unacceptable frequency of an adverse event
- A detected fraudulent product
- Cancelation of registration,
- Selling of medicines illegally in South Africa
- An error on the label or package insert of the product or any problem identified by the HCR that may present a hazard to public health.
Benylin Paediatric Syrup (each 5 ml contains 7 mg Diphenhydramine HCl)
|
Company name & Address |
Registration number |
Batch number |
Expiry date | Size | First distributed |
Re-call Classification |
Recall date |
|
241 Main Road, Retreat 7945, Cape Town, South Africa |
H/10.1/12 |
329303 |
April 2024 |
100ml glass bottle |
11 June 2021 |
Class I Type A
|
11 Apr 2024 |
Reason for recalls
On 10 April 2024, the South African Health Products Regulatory Authority (SAHPRA) received a report from National Agency for Food and Drug Administration and Control (NAFDAC) regarding detection of high levels of Diethylene glycol in a batch of Benylin Paediatric medicine. SAHPRA immediately contacted the manufacturer Kenvue (formerly Johnson and Johnson) for a response. Following engagements with the manufacturer, it was resolved that affected batches would immediately be recalled whilst investigation is ongoing.
SAHPRA, in collaboration with the South African manufacturer, Kenvue (Johnson and Johnson) have identified the affected batch numbers as 329304 and 329303 and identified the following countries to which these batches have been distributed: South Africa, Eswatini, Rwanda, Kenya, Zambia, Tanzania and Nigeria.
Advice to HCPs/Distributors/Public
The company urges the public and requests all their clients to refrain from selling or consuming any of the affected batches of Benylin® Peadiatric Syrup and to return these to their supplying warehouse or distributor for full credit with immediate effect.
Proposed action taken and its urgency:
A SAHPRA approved recall letter has been distributed to all distribution points and the recall process has been initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Lubri-A sterile lubricating sachets (Glycerine (B.P. or U.S.P) 9.9% m/m)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
| EletroSpyres HealthCare
9 Friesland Drive, Westfield, Modderfontein, Johannesburg, 1609, South Africa |
00001323MD |
M204;M205;M085; M108; M156; M109 |
M204(2026-05-30); M205(2026-06-22); M085(2026-01-03) M108(2026-01-03); M156(2026-01-26) |
2,5 g sachet |
Oct.2022 |
Class I Type A |
18.Dec.2023 |
Reason for recall
The recall was initiated because of numerous complaints received by SAHPRA due to a countrywide outbreak across the country regarding patients who developed a rare fungal pathogen, Wickerhamomyces anomalus (previously Candida pelliculosa), following the use of Lubri-A use. Following a collaborative outbreak investigation, the source was found to have contaminated several batches of the product, Lubri-A-Sterile Lubricating 2.5 g Jelly sachets.
Advice to HCPs/Distributors/Public:
The company requested their clients countrywide to stop using the affected product batches and return all units on hand of the affected batches to their supplying wholesaler or distributor immediately for a full replacement product.
- EletroSpyres HealthCare also urged their clients to reach out to the company’s dedicated product recall hotline at: 011-608-3998 or on What’s App: 082-355-8862 or email them at sales@electrospyres.com.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Amuco 600 Effervescent Tablet (Acetylcysteine 600mg)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
| Austell Pharmaceuticals
1 Sherborne Road Parktown 2193, South Africa |
47/10.2.2/0477 |
42332, 42333, 42334, 42386, 42387, 42388, 42389 (see customer letter for more batches) |
May.2024 |
1 tube of 10 tablets |
Sep.2023 |
Class III Type C |
24.May.2023 |
Reason for recall
The recall was initiated because some of the containers possess defective primary packaging, resulting in the loosening of the seal on certain packages. The company confirmed that this faulty seal, combined with the hygroscopic nature of the product, causes the product to become moist.
Advice to HCPs/Distributors/Public:
The company requested their clients to immediately return all units on hand of the affected batches to their supplying wholesaler or distributor for a full credit.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Bemetrazole 400mg Tablets (Metronidazole)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First date of release |
Re-call Classification |
Recall date
|
| Ranbaxy Pharmaceuticals (Pty) Ltd
14 Lautre Road, Stormill Extension 1. Roodepoort, Johannesburg 1724, South Africa |
X/20.2.6/84 |
AC80212 and AC80213 |
08/2024 (both batches) |
500’s
|
26.Sep.2022 (both batches) |
Class II Type B
|
18.Aug.2023 |
Reason for recall
This recall was initiated due to discolouration of tablets.
Advice to HCPs/Distributors/Public:
The company requested their clients to refrain from selling any of the affected batches of Bemetrazole 400mg, Batch AC80212 and AC80213, and to return all remaining stock to their supplying warehouse or distributor with immediate effect. Ranbaxy Pharmaceuticals (Pty) Ltd will collect all your stock which will be credited.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Arthrexin 25 capsules (indomethacin 25mg)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
| Pharmacare Limited t/a Aspen Pharmacare, Healthcare Park, Woodlands Drive, Woodmead, Sandton 2196, South Africa |
K/3.1/285 |
P0003739 |
Jan.2025 |
100’s |
Sep.2023 |
Class III Type C |
05.Feb.2024 |
Reason for recall
The recall was initiated because of an error of incorrect labelling found on some containers. The complainant (pharmacy) found Arthrexin 25 mg capsules in a container labelled as Arthrexin 50 mg capsules.
Advice to HCPs/Distributors/Public:
The company requested their clients to immediately return all unit containers to their wholesaler or distributor for a full credit, without delay.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Novomix Injection 30 Penfil, 3 ml (100 units of Insulin Aspart)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First date of release |
Re-call Classification |
Recall date
|
| Novo Nordisk (Pty) Ltd,10 Marion Office Park, Building C1,150 Rivonia Road, Sandton |
35/21.1/0031 |
NR7SE13 |
June.2025 |
5’s
|
16.Nov.2023 |
Class II Type B
|
08.Jan.2024 |
Reason for recall
This recall was initiated due to incidents of cracked cartridges found in cartridge batches from cartridge supplier and used for filling of the insulin product.
Advice to HCPs/Distributors/Public:
The company requested their clients to refrain from selling any of the affected batch of Novomix® 30 Penfill® and to return them to their supplying warehouse or distributor with immediate effect for full credit.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Semaglutide (API)
| Company name & Address | registration number | Batch number | Expiry date | Pack size | First distributed |
Re-call Classification |
Recall date |
|
Marsing & Co. Africa (Pty) Ltd, 9 Thunderbolt Lane Lanseria Corporate Estate, Malibongwe Drive Lanseria Johannesburg |
Not registered with SAHPRA |
23022832 |
21.Mar.2025 |
N/A |
08.Aug.2023 |
Class I Type A
|
04.Dec.2023 |
Reason for recall
Marsing & Co. Africa (Pty) Ltd, took the decision to initiate a recall of the batch 23022832. The recall was due to the importation of unauthorised substance (API) not included on the product list as per Section 22C (1)(b) Licence. In addition, this recall is initiated because the substance has not been evaluated or registered in South Africa thus safety, efficacy and quality of the substance and any products compounded containing this substance have not been established by SAHPRA. The semaglutide, said to be found in this unauthorised substance, may contain unexpected impurities or degradation products which can have unknown effects on patients using this unevaluated substance.
Advice to HCPs/Distributors/Public:
The company requested their clients to refrain from dispensing this API, Batch No. 23022832 and to return all remaining stock to their supplying warehouse or distributor with immediate effect
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process has been initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
0.9% Sodium Chloride Infusion B. Braun solution for infusion (9mg/ ml sodium chloride)
|
Company name & Address |
Registration number |
Batch numbers | Expiry date | Pack size | First distributed date |
Re-call Classification |
Recall date |
|
B.Braun Medical (Pty) Ltd 253 Aintree Avenue, Hoogland Ext.41 Northriding, 2169 Gauteng, South Africa |
41/24/0432
|
21154408
21155407 |
31/03/2024
31/03/2024 |
50ml |
03 May 2021
03 May 2021 |
Class II Type B
|
02 August 2023 |
Reason for recall
B.Braun in consultation with the SAHPRA has taken a decision to recall their 0.9 % Sodium Chloride Infusion solution due to cross-contamination. They have been informed by their mother company in Germany regarding batches of solutions for infusion produced after Midazolam solution for infusion were detected to be cross-contaminated with traces of Midazolam above the PDE (Permitted Daily Exposure).
Advice to HCPs/Distributors/Public:
The company has requested the following from their customers:
- Do a visual check of the above-mentioned batches and separate
- Contact the customer you have supplied and arrange for return of the product to the hub if you are a wholesaler or distributor of the product. B.Braun will collect from your facility.
- Contact the B.Braun Customer Services Interaction Center for upliftment of the relevant
Proposed action taken and its urgency: Any remaining stock is to be quarantined, stock is to be blocked for sale by all distributors. The SAHPRA approved recall letter is to be distributed to all clients and recall process initiated as per recall guideline.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Dopaquel 300mg film-coated tablets (Quetiapine fumarate)
| Company name & Address | registration number | Batch numbers | Expiry date | Pack size | First distributed date. |
Re-call Classification |
Recall date |
|
Dr Reddy’s Laboratories (Pty) Ltd Block B, 204 Rivonia Road Morningside Sandton 2057 South Africa. |
43/2.6.5/0432
|
C2300635 |
11/2025 |
60s |
24 February 2023 |
Class III Type C
|
07 July 2023 |
Reason for recall
Dr Reddy’s Laboratories (Pty) Ltd, in consultation with the SAHPRA has taken a decision to recall Dopaquel 300mg film-coated tablets due to a complaint that was received in the above listed batch with a foreign plastic particle embedded in a broken tablet.
Advice to HCPs/Distributors/Public:
- Distribution and sale of the above-mentioned products should be ceased and immediate quarantine of any units of the above-mentioned batch that they have in their possession and must be returned via their normal distribution channel for full credit.
- Customers are requested to retain the notification letter and place it in a prominent position for one month.
Proposed action taken and its urgency: Any remaining stock is to be quarantined, stock is to be blocked for sale by all distributors. The SAHPRA approved recall letter is to be distributed to all clients and recall process initiated as per recall guideline. The affected batch was only distributed within South Africa.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
PHOLTEX SYRUP Range: Pholtex Junior; Pholtex Forte and Pholtex Plus
(Pholcodine 5 mg, Pholcodine 15 mg and Pholcodine 5 mg; Phenylephrine HCl 3.3 mg respectively)
| Company name | Registration number | Batch numbers | Expiry date | Pack size | First distributed date | Re-call Classification | Recall and withdrawal date |
| iNova Pharmaceuticals (Pty) Ltd, 15E Riley Road, Bedfordview, 2007, South Africa. | 29/10.1/0013
32/10.1/0116
46/16.5/0711 |
All batches | All batches with expiry dates | 100 ml and
200 ml |
All batches available.
|
Class II Type B |
29 Mar 2023 |
Reason for recall
iNova Pharmaceuticals (Pty) Ltd, in consultation with the SAHPRA has taken a decision to recall AND to withdraw all pholcodine containing medicines.
The decision to recall AND to withdraw is linked to a recently concluded French clinical study (the ALPHO Study) which reviewed a possible association between pholcodine and very rare but serious anaphylactic reactions to medicines called neuromuscular blocking agents (NMBAs) used in anaesthesia. iNova, based on SAHPRA’s recommendation has agreed to recall all stock in the market & withdraw the product completely from the market.
Data from the ALPHO study indicates that the use of pholcodine in the 12 months leading up to anaesthesia using NMBAs increases the risk of developing an anaphylactic reaction. The relationship between pholcodine and anaphylactic reactions to NMBAs has been hypothesised over the last decade, however, until the ALPHO study, no association had previously been established in any clinical study globally. It is further confirmed that there is still no evidence showing causal risk. However, based on the available data, there are currently no possible effective risk minimization measures which have been identified to mitigate against this risk, nor to identify a patient population for whom the benefits of pholcodine outweigh the risks. Due to these considerations and the nature of the adverse reactions (including its unpredictability and clear timelines to onset), SAHPRA has recommended the withdrawal of all pholcodine-containing medicines from the South African market.
Advice to HCPs/Distributors/Public:
- Distribution and sale of the above-mentioned products should be ceased immediately.
- All batches of Pholtex Junior, Pholtex Forte and Pholtex Plus are to be returned to wholesaler/distributor.
- Customers are requested to retain the notification letter and place it in a prominent position for one month in case stock is in transit.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all clients, stock is blocked for sale by all distributors and recall initiated. This incident has been reported to other Reg Authorities, namely: NMRC, MCAZ, ZAMRA and BoMRA.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
CP Sports Infusion” (Glutathione: 2g/50ml)
Other ingredients: [Thiamine: 260mg/50ml; Riboflavin: 2mg/50ml; Nicotinamide: 100mg/50ml; Pyridoxine: 5mg/50ml; D- Panthenonate: 5mg/50ml;
Magnesium: 1g/ 50ml and Methylcobalamin: 250ug/50ml]
| Company name & Address | registration number | Batch number | Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
|
Compounding Pharmacy of South Africa (CPSA). 2 Eaton Avenue, |
N/A (product by compounding pharmacy) |
IV44762;
IV44821;
IV44830;
IV44856 |
IV44762: IV44821: IV44830: IV44856 |
50ml injectable vial |
IV44762: 05-10-2022; IV44821: 10-10-2022; IV44830: 11-10-2022; IV44856: 12-10-2022 |
Class I Type C
|
21 Oct |
Reason for recall
The recall is due to reports of patients that have reacted to IV medicines, compounded by CPSA, and issued on prescription to medical practices. The medical practitioners of these patients communicated the information to the Compounding Pharmacy (the recall was initiated after the company (CPSA) was notified of patients being hospitalized). Details of complaints: 1 complaint: Nausea, vomiting, body aches, tachycardia, muscle weakness, headaches & shivers.
35 Complaints: Nausea, vomiting, body aches, tachycardia, muscle weakness, headaches & shivers.
Advice to HCPs/Distributors/Public:
The company requested their clients to refrain from dispensing the affected batches. An urgent notification (letter) was sent to all practices that received IVs containing the affected batches, as well as additional batches as a precautionary measure with immediate effect.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all clients and recall initiated.
distributed to all distribution points and recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Zodoray 0.25 μg capsules (Alfacalcidol).
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First date of release |
Re-call Classification |
Recall date
|
| Strides Pharma SA (Pty) Ltd.
Address: 106 16th Road, Building 2, Midrand, 1686, South Africa. |
53/22.1.4/0679 |
BN 7250117 |
Dec. 2023 |
30’s
|
19.Jul.2022 |
Class II Type C
|
30.Jan.2023 |
Reason for recall
This recall is initiated due to an out of specification result for the assay test at 3 months testing interval at long term storage conditions i.e., 25°C/ 60%RH.
Advice to HCPs/Distributors/Public:
The company requested their clients to quarantine and refrain from selling any of the affected batch of Zodoray 0,25 µg capsules and return them to their supplying warehouse or distributor with immediate effect for reimbursement.
Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
FLOMIST NASAL SPRAY (Fluticasone Propionate 50 mcg/ spray)
| Company name & Address | registration number | Batch number | Expiry date | Pack size | First distributed |
Re-call Classification |
Recall date |
|
Cipla Medpro (Pty) Ltd, Parc du Cap Building 9, Mispel Street, Bellville, 7530, South Africa |
37/21.5.1/0289 |
IC20685 |
Nov.2024 |
1 x 120 MD |
28 Sept.2022 |
Class II Type B
|
12.Dec. 2022 |
Reason for recall
The recall is due to an out of specification (OOS) result that was observed in Flomist nasal spray, batch no. IC20685. OOS result was observed in microbial enumeration test. The organism was identified as Burkholderia Cepacia
Cipla Medpro (Pty) Ltd, in South Africa took the decision to initiate a voluntary recall on batch IC20685.
Advice to HCPs/Distributors/Public:
The company requested their clients to refrain from selling or dispensing FLOMIST NASAL SPRAY, Batch No. IC20685 and to return all remaining stock to their supplying warehouse or distributor with immediate effect
Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
CELESTONE SOLUSPAN Suspension for injection (Betamethasone acetate/ Betamethasone sodium phosphate suspension)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
| Organon South Africa (Pty) Ltd
Spaces, 1st Floor 22 Magwa Crescent, Gateway West Waterfall City, Midrand, 2090 South Africa |
G2963 (Act 101/1965) |
W002691
U040010 W007137 NB: more batches found in the recall notification. |
Batch W002691: 03.2023 Batch U040010: 04.2023 Batch W007137: 05.2023 |
1ml, 2ml & 5ml |
29.Mar.2022
22.Feb.2022
21.Jun.2022 |
Class III Type C |
01.Feb.2023 |
Reason for recall
The recall is initiated because of the company’s use of a potentially corroded component in the manufacturing of the products at Heist. The use of the potentially corroded component creates the potential for stainless steel particulates in the formulations.
Advice to HCPs/Distributors/Public:
The company requested their clients to refrain from selling any of the affected batch(s) of CELESTONE SOLUSPAN Suspension for injection and to return them to their supplying warehouse or distributor with immediate effect. DSV Healthcare (Pty) Ltd will collect all their stock, which will be credited.
Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and recall initiated
distributed to all distribution points and recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Lumont 10 mg tablets (montelukast)
| Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
|
Zydus Healthcare SA (Pty) Ltd. Southdowns Office Park, 22 Karee Street, Centurion, 0157
|
4/10.2.2/0792 |
108011 |
31/05/2024
|
30s |
30/08/2021 |
Class II Type B
|
17.Oct.2022 |
Reason for recall
Zydus Healthcare SA (Pty) Ltd took the decision to initiate a voluntary recall on Lumont 10 mg tablets. The recall is instituted due to out of specification results observed in dissolution test at 12 Month(s) time point interval in long term condition i.e., 30°C/75% RH.
Advice to HCPs/Distributors/Public:
The company requests all customers to refrain from selling or dispensing stock from the affected batch. Undistributed stock on hand placed on quarantine with immediate effect. All affected returned stock will be replaced free of charge.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Lasix 80 mg tablets (furosemide 80 mg)
| Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
|
Sanofi Aventis South Africa (Pty) Ltd/Zentiva Pharmaceuticals (Pty) Ltd 5th Floor Building I Hertford Office Park 90 Bekker Road Vorna Valley, Midrand
|
V/18.1/9 |
CG022A |
12/2023 |
30s |
22/04/2022 |
Class II Type C
|
17.Oct.2022 |
Reason for recall
Sanofi Aventis South Africa (Pty) Ltd took the decision to initiate a voluntary recall on Lasix tablets 80 mg. The recall is instituted following the detection of a dissolution failure at the 6 months testing interval. The results for dissolution were below the required 80% after 60 minutes.
Advice to HCPs/Distributors/Public:
The company requests and urges their customers to return all stock on hand of Lasix 80mg tablets 30s, batch: CG022A to their relevant distributor and/or wholesaler as soon as possible for reimbursement.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Mizart 80 mg tablets (telmisartan 80 mg)
| Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
|
Viatris South Africa (Pty) Ltd 4 Brewery Street Isando, Gauteng, 1609
|
45/7.1.3/0607 |
8130141
|
10/2024
|
30s |
08/03/2022 |
Class II Type B
|
10.Oct.2022 |
Reason for recall
Viatris South Africa (Pty) Ltd took the decision to initiate a voluntary recall on Mizart 80 mg tablets. This recall is initiated in view of a complaint received, regarding comingling of tablets in a securi-tainer of Mizart 80 mg (30’s).
Advice to HCPs/Distributors/Public:
The company requested customers to refrain from selling Mizart 80mg tablets of the affected batch (batch nr. 8130141) and return it to their supplying warehouse or distributor with immediate effect. The applicant confirmed that they will ensure that the stock of batch 8130141 is replaced to their customers.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Andolex-C Oral Gel (benzydamine HCL 10 mg/cetylpyridinium Cl 1 mg/g)
| Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
|
iNova Pharmaceuticals (Pty) Ltd 15E Riley Road, Bedfordview, 2007
|
33/16.4/0285
|
126355
127226
|
02/2025 04/2025
|
10 g tube |
Batch 126355: 08/04/2022 Batch 127226: 26/05/2022 |
Class III Type C
|
07.Oct.2022 |
Reason for recall
iNova Pharmaceuticals took the decision to initiate a voluntary recall on Andolex-C Oral Gel. The recall is instituted due to Stability data assessed at 3 and 6 months which showed an out of specification result on microbiological growth on both batches and the assay value of Cetylpyridinium Chloride which tested below approved limits for batch 127226.
Advice to HCPs/Distributors/Public:
The company requested immediate blockage of stock on hand of the batches mentioned above, and for the distributors to be in contact with their customers who purchased the affected stock.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Austell Azithromycin (Azithromycin 200 mg/5 ml powder for suspension)
| Company name & Address | Registration number | Batch number | Expiry date | Pack size | First distributed | Re-call Classification | Recall date |
|
Austell Pharmaceuticals 1 Sherborne Road Parktown 2193, South Africa |
A50/20.1.1/0567 |
MG22413 MG22414
MG22415 |
04/2027 04/2027 05/2027 |
15 ml | 11/07/2022 | Class III Type C |
29.Sept. 2022 |
Reason for recall
Austell Pharmaceuticals took the decision to initiate a voluntary recall on Azithromycin 200 mg/5 ml Powder for suspension. The recall is instituted due to some of the containers having defective primary packaging resulting in the seal being discoloured, which is not in line with the product specifications.
Advice to HCPs/Distributors/Public:
The company requested immediate return of all units on hand of the batches mentioned above to their supplying wholesaler or distributor for a full credit.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all distribution points, recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Vitaforce Schlehen Blackthorn Berry Elixir (Ascorbic acid (Vit C) 33,5 mg)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
Re-call Classification |
Recall date |
| Ascendis Consumer Brands (Pty) Ltd, 1 Carey Street, Wynberg, Sandton, Gauteng |
N/A (Category D product) |
151717 151848 151725 151844 152003
|
BatchNo:151717 Exp date:12/2024 Batch No:151848 Exp Date 02/2025 Batch No:151725 Exp Date: 02/2025 Batch No: 151844 Exp Date:03/2025 Batch No:152003 Exp Date 05/2025 |
200 ml and 500 ml
|
Class III Type C
|
09.Sept.2022 |
Reason for recall
The products are being re-called due to quality defect: The company received a complaint from a customer who indicated that the product is foamy and smells fermented.
Advice to HCPs/Distributors/Public:
Affected stock has been blocked for distribution and the applicant requested their clients for immediate return of the affected batch.
Proposed action taken and its urgency: The recall is initiated; a SAHPRA approved recall letter to be distributed to all distribution points.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
JANUMET 50/850mg and JANUMET 50/1000mg (50mg of Sitagliptin with 850mg of Metformin Hydrochloride AND 50mg of Sitagliptin with 1000mg of Metformin Hydrochloride)
| Company name & Address: |
Product |
registration number |
Batch number(s) |
Expiry date(s) |
Pack size |
|
Re-call Classification |
Recall date |
| 117, 16th Road, Midrand, South AfricaPrivate Bag 3, Halfway House, 1685 |
JANUMET 50/850mg
|
42/21.2/1090 |
W01552
W01553 |
2023/10/31
2023/10/31
2023/10/31
|
28s
28s |
2022/07/06
2022/07/18 |
Class III Type C
|
05.Sept.2022
|
|
JANUMET 50/1000mg |
42/21.2/1091 |
W015798 | 2023/11/30 | 28s | 2022/07/18
|
Class III Type C |
05.Sept.2022 |
|
| W015803 | 2023/11/30 | 28s | 2022/07/06
|
|||||
| W017752 | 2023/11/30 | 28s | 2022/07/27
|
|||||
| W018077 | 2023/11/30 | 28s | 2022/08/02
|
|||||
| W021662 | 2024/01/31 | 28s | 2022/08/12 |
Reason for recall
The products are being re-called due to quality defect; the company initiated a recall because the above batches are not in compliance with the registered requirements for the South African market, as follows:
- The incorrect artwork for both the packaging insert and the unit carton. The languages are in English and Portuguese and should be in English and Afrikaans per the local market requirements.
- The packs do not contain a Patient Information Leaflet.
- The material for the primary packaging is not registered for the local market.
- The sold packs do not have the SA registration on the artwork
Advice to HCPs/Distributors/Public:
The company has requested the customers to refrain from selling any of the affected batch(s) of the JANUMET 50/850 mg and 50/1000mg packs and return to them to their supplying warehouse / distributor with immediate effect.
Proposed action taken and its urgency: The recall has id initiated; a SAHPRA approved recall letter to be distributed to all distribution points
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Rocephin 1G injection (1 vial with dry substance equivalent to 1g ceftriaxone + 1 ampoule water for injection 10ml)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Roche products (Pty) LtdBuilding E, Hertford Office Park90 Bekker Road, Midrand
1686 |
R/20.1.1/46 |
B0757B04
|
31-03-2024 |
1 |
Mar-2021
|
Class I Type C |
1 July 2022 |
Reason for recall
The products are being recalled due to quality defect: Pinholes were found on the 10ml Water for Injection that is co-packaged with the Rocephin 1g Vial. These pinholes are melting defects located at the top of the ampoule head and surrounded by concavity.
Advice to HCPs/Distributors/Public:
Affected stock has been blocked for distribution and the applicant requested their clients for immediate return of the affected batch of Rocephin 1G Vial pack to the
supplying wholesaler or distributor for full credit.
Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, recall Initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Adco-Napacod tablets (Paracetamol 500 mg and Codeine Phosphate 10mg)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Adcock Ingram Limited.
1 New Road, Midrand, 1685 |
B/2.8/1401 |
AD0433
AC1264 |
02-2026
06-2025 |
1000’s |
25 June-2021
08 Oct-2020 |
Class II Type B |
23 June 2022 |
Reason for recall
The products are being recalled due to quality defect: the company received customer complaints reporting discoloration of tablets and/or discoloured silica gel (complaints were either about discoloured silica gel sachets only or discoloured silica gel sachets and tablets with which the sachets had direct contact).
Advice to HCPs/Distributors/Public:
Affected stock has been blocked for distribution and the product placed on hold at Adcock Ingram distribution centers.
Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, recall Initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Coryx Throat Spray (Benzocaine and chlorhexidine gluconate solution 20 %).
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First date of release |
Re-call Classification |
Re-call Date |
||||||||
|
|
ZB000156,
ZB000157, ZB000158, ZB000159, ZB000160, ZB100105, ZB100107 ZB100172
|
10.2022
10.2022 10.2022 10.2022 10.2022 02.2023 02.2023 03.2023 |
100 ml |
04.02.2021
04.02.2021 09.02.2021 09.02.2021 09.02.2021 14 & 15.06.2021
21. 06.2021 |
Class I Type A
|
15 June 2022 | ||||||||
Reason for recall
Cipla Medpro (Pty) Ltd, in collaboration with SAHPRA, is recalling the above-mentioned batches of Coryx Throat Spray.
The reason for the Class I Type A product recall is the remote possibility that the spray nozzle may detach from the spray mechanism during use:
The company received two product complaints from two customers (1st customer on 04.06.2021 & 2nd customer on 06.12.2021) who purchased a bottle of Coryx Throat Spray.
Customer 1: The customer complained that the spray nozzle came off and was stuck in his throat, he was not able to remove it and the cap was swallowed. The customer further explained that his throat was damaged trying to remove the cap.
Customer 2: The customer complained that the spray nozzle of the bottle came off while he was using it and he involuntarily swallowed it.
Advice to HCPs/Distributors/Public:
All affected stock/ batches should be removed from the client’s inventory with immediate effect and returned via the normal distribution channel. The recall applies to all distribution points i.e. wholesalers throughout the country, hospital services (private as well as state hospitals), retail outlets, doctors, nurses, pharmacists, authorised prescribers and dispensers and individual customers or patients.
Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all the above-mentioned distribution points and an approved press statement released to public. Immediate recall has been initiated.
Media release Publication: eNCA Headline: Cipla recalls batches of Coryx throat spray
Link: https://www.enca.com/business/cipla-recalls-batches-coryx-throat-spray
Media Coverage confirmation: Coryx Throat recall
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Demetrin 10mg (prazepam)
| Company name & Address | Registration number | Batch number | Expiry date | Pack size | First distributed |
Re-call Classification |
Re-call Date |
|
Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton South Africa |
G/2.6/188 |
DT3236 |
28 Feb-2023 |
100’s |
21 July-2020 |
Class II Type B
|
4 July 2022 |
Reason for recall
The recall is due to out of specification results for dissolution during stability studies, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Demetrin 10 mg, batch DT3236.
Advice to HCPs/Distributors/Public:
The company requested the return of all stock of the affected batch to the supplying distributor/wholesaler for full credit without delay.
Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Accumax 10mg and 20 mg Film Coated Tablet (QUINAPRIL HYDROCHLORIDE)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Pfizer Laboratories (Pty) Ltd
85 Bute Lane, Sandton, South Africa |
34/7.1.3/0230 |
CK8048, DC6880 and DM5063 |
28/02/2022 |
30s 10 mg |
19-Oct-2019
30-Mar-2020
10-Jun-2020 |
Class II Type B |
25 April 2022 |
| Pfizer Laboratories (Pty) Ltd
85 Bute Lane, Sandton, South Africa |
34/7.1.3/0231 | DM5060,
EA7796 and, |
31/12/2022
|
30s 20 mg | 20-May-20,
28-Sep-20
24-Jan-20 |
Class II Type B | 25 April 2022 |
| AW1957, CM2638
|
28/02/2022 | 24-Jan-20
|
Reason for recall
This product is being recalled due to a quality defect: N-Nitroso-quinapril was detected in Accumax batches tested to be above the Acceptable Daily Intake. According to the Applicant, the nitrosamine (N-Nitroso-quinapril) detected in this product is a newly identified one.
The acceptable daily intake limit (AI) calculated should be 18 ng/day.
Advice to HCPs/Distributors/Public:
An Immediate batch tracing, quarantine of stock from all distributors & their clients was conducted. Also, an immediate notification to recall the batches was sent to the regulatory Authority (SAHPRA). A recall letter was distributed to all healthcare professionals via medpages.
Customers were advised, in a form of a recall letter, to return the units of the batches listed in the table to their supplying distributor/wholesaler for full credit without delay.
For further product information or medical queries, please address this to: Pfizer’s Medical Information on 0860 734 937 (or email at Med.Info2@Pfizer.com ).
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
PROTA 50 mg/ 5 ml (Protamine Sulphate - Ampoules for IV injection)
| Company name &
Address |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
|
Equity Pharmaceutica ls (Pty) Ltd, 100 Sovereign Drive, Route 21 Corporate park, Irene, Pretoria, South Africa, 0157 |
N/A (Section 21, Unregistered) |
IPTAA1203 | 31.12.2023 | 25’s |
11/2020 |
Class II Type B |
26 May 2022 |
Reason for recall
The product was being recalled due to quality defect: Floaters that look like mould were found inside a few number of ampoules.
Advice to HCPs/Distributors/Public:
As a safety precautionary measure, due to affected units found, Equity Pharmaceuticals (Pty) Ltd recommends that healthcare providers should immediately discontinue the use of PROTA injection and to return all units of PROTA to Equity Pharmaceuticals (Pty) Ltd. and send an email to section21@equitypharma.co.za to arrange for upliftment and credit. They are also advised to retain the recall letter in a prominent position for one month.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Lactulose concentrate API (Lactulose Concentrate solution- 66% and 70% )nsoprazole).
| Manufacturer name
& Address |
Customers |
Batch number |
Manufacturing Date |
Expiry dates |
Batch release date |
Quantity dispatched to customer |
Re-call Classification |
Re-call Date |
| Lacsa (Pty) Limited
72 Ballantrae Road, Merebank, Durban, South Africa |
Pharmchem Lab | P3915 | 17.Sept.2021 | 11Aug-2025 | 24.Aug.2021 | 840 kg | Class II Type B | 18 May 2022 |
| Relax Limited | P3822, P3823,
P3841, P3912,P3913 P3915, P3916,P3919, |
11.Jan.2021,
13.Jan.2021, 31.Oct.2020, 07.Aug.2021, 11.Aug.2021 |
10.Jan.2025,
13.Jan.2025 31.Oct.2024 07.Aug.2025 13.Aug.2025 |
25.Jan.2021
08.Feb.2021 11.Mar.2021 30.Aug.2021 24.Aug.2021 |
696 060 kg | Class II Type B | 18 May 2022 |
Reason for recall
The product was being recalled due to quality defect:The product was found to have microbial counts with yeast (Millerozyma farinose) and mould; the count was above specification. Out of Specification results were then reported by customer whilst using customer method (undiluted), which was confirmed by the manufacturer using customer method. The recall was requested based on the presence and count of the organism.
Recall process: Recall letters have been distributed to all Distributors.
Advice to HCPs/Distributors/Public:
The manufacturer requested for the immediate return of all the affected batches of Lactulose concentrate API to the supplying distributor without delay. As a precautionary measure, distribution remains on hold for all stock on site at the manufacturer and no manufacturing is taking place until corrective measures are confirmed.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Lancap 15mg capsules (Lansoprazole).
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First date of release |
Re-call Classification |
Recall date
|
| Pharma Dynamics (Pty) Ltd Floor 1, Grapevine House. Steenberg Office park, Silverwood close, Westlake, Cape Town, South Africa 7945 |
A40/11.4.3/0247 |
SJ2758 SJ3425 SJ2652 SJ8693 |
Mar 2024 Nov 2023 Mar 2024 Aug 2024 |
14’s
|
10.Sep.2021 22.Sept.2021 13.Sept.2021 15.Mar.2022 |
Class III Type C
|
12.Sep.2022 |
Reason for recall
This recall is initiated due to detection of non-conformances to the Medicines and Related Substances Act (Act 101 of 1965), in terms of the printed packaging material packaging material of LANCAP 15 mg (14 capsules): The schedule as per the carton [S4] does not align to the consolidated schedules, in that a product containing 15 mg of Lansoprazole as a maximum daily dose and for a maximum treatment period of 14 days is indicated under S2. The indication per the carton (for the relief of heartburn and hyperacidity) is in line with S2 of the consolidated schedules, however this does not align with the S4 scheduling included on the carton.
Advice to HCPs/Distributors/Public:
The company requested their clients to quarantine, refrain from selling and to return all inventory of LANCAP 15 mg (14 capsules), [S4] medication to their relevant distributor and/or wholesaler with immediate effect for reimbursement.
Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Oranix Solution (oral rinse) (Benzydamine HCl 22,5 mg/15 ml; Chlorhexidine gluconate 18,0 mg/15 ml)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| iNova Pharmaceuticals (Pty) Ltd
15E Riley Road, Bedfordview, 2007 South Africa |
34/16.4/0391 |
126189 |
11/2023 |
200 ml |
13.12.2021 |
Class III Type C |
28 January 2022 |
Reason for recall
This product is being recalled due to a complaint relating to quality defect: The assay of the active pharmaceutical ingredient, chlorhexidine gluconate, is below approved specification and the efficacy of this product cannot be guaranteed, (Assay limit of Chlorhexidine Gluconate ut of specification).
Advice to HCPs/Distributors/Public:
Immediate batch tracing, quarantine of stock from all distributors & their clients, immediate notification to recall the batches
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
OsvaRen 435mg_235 film coated tablets
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Fresenius Medical Care South Africa (PTY) Ltd. 9 Galaxy Ave. Frankenwald Sandton 2090, South Africa |
45/24/0919 |
ZC015 200, ZOAK08100, ZOAK04 200, ZC016100, ZOAK04300, ZOAK05200, ZOAK08300 |
2.2021 (old), 30.07.2022 (new) 9.2021 (old), 31.07.2022 (new) 2.2021 (old),12.20 21 (new) |
180s |
04/10/2019 |
Class III Type B |
22 April 2022 |
Reason for recall
This product is being recalled due to a complaint relating to quality defect: Complaint on the final product packaging of Osvaren 435mg/ 235m g film- coated tablets (a secondary label with new expiry date affixed on top of the originally printed one).
Advice to HCPs/Distributors/Public:
Immediate batch tracing, quarantine of stock from all distributors & their clients, immediate notification to recall the batches sent to the regulatory authority.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
DERMADINE ORAL ANTISEPTIC solution (Povidone-iodine 1,00 g (1 % m/v))
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Cipla Medpro (Pty) Ltd, Cipla Head Office, Parc du Cap, Building 9, Mispel Street, Bellville, Bellville,Cape Town, 7530, South Africa |
H1511 (Act 101/1965) |
120983 |
October 2022 |
200 ml |
September /2020 |
Class III Type C |
24 January 2022 |
Reason for recall
This product is being recalled due to a complaint relating to quality defect: The impacted batch of Dermadine Oral antiseptic solution was deemed to be defective and did not comply with the requirements of Act 101 of 1965 in terms of the product specification, Solution is clear – no iodine colour, smell or taste, (lack of efficacy).
Advice to HCPs/Distributors/Public:
Please refrain from selling or dispensing this batch. Stock of the affected the batch is re-called from the wholesalers and direct retailers, including cross- border customers, utilising company representatives.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Azacitidine DRL 100mg Lyophilized powder for Injection (Azacitidine)
| Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Dr. Reddy’s Laboratories Limited, Chemical Technical Operations, Unit- I, Plot No. 137,138, 145
& 146 |
51/26/0144 |
H210418 |
Mar/2023 |
Vial: 30ml |
2021/10/06 |
Class III Type C |
11 January 2022 |
Reason for recall
The products are being recalled due to quality defect: The company initiates an immediate recall of the following batches of the products, as listed above, following detection during periodic re-qualification of VHP (Vaporized Hydrogen Peroxide) decontamination cycle executed at Dr. Reddy’s Formulation Unit-07, for the Filling Isolator Equipment PR-E235 & PR-E3 l 8 (Zone 1 + 3) in Line-1, Biological Indicator (BI) failure observed at locations pertaining to ISl0- Lyo loading & unloading area. Root Cause: From the investigation it was concluded that the failure of VHP requalification run was due to improper distribution of the vaporized hydrogen peroxide vapours inside the isolator. The probable reason for the failure was due to the presence of polybags in the VHP distribution lines of Isolator IS10.
Advice to HCPs/Distributors/Public:
The action was initiated to halt and facilitate return of any potential product available at wholesale level. Distribution points will be requested to return the impacted product via their routine distribution channel to receive credit for the relevant quantities returned. All product impacted in South Africa was quarantined at the warehouse facility and reconciled against the quantity distributed.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
LOSAAR PLUS 50/12.5 TABLETS 30'S (losartan 50 mg, hydrochlorothiazide 12,5 mg) and LOSAAR PLUS 100/25 TABLETS 30'S (losartan 100 mg, hydrochlorothiazide 25 mg)
| Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
|
Accord Healthcare (Pty) Ltd, Building 2, Tuscany Office Park 6 Coombe Place, Johannesburg, South Africa |
50/12.5mg: 42/7.1.3/0325 |
01523, 000919, 000920, 01870 |
May 2023 Jul 2023 |
30 |
July 2020 |
Class II Type B |
6 October 2021 |
| 100/25 mg:
46/7.1.3/0715 |
00915, 00916,
00917, 00918 |
May-2023 | 30 | July 2020 | Class II Type B | 6 October 2021 |
Reason for recall
The products are being recalled due to quality defect: The company initiated an immediate recall of the following batches of the products, as listed above, following the detection of an azido impurity in the losartan active ingredient. The impurity, also known as 4-chloro azido methyl tetrazole is formed during the manufacture of the active ingredient.
Advice to HCPs/Distributors/Public:
Healthcare professionals are urged to return all stock on hand of the above batches of LOSAAR PLUS 50/12,5 and LOSAAR PLUS 100/25 to their relevant distributor and/or wholesaler as soon as possible for reimbursement. Please retain this letter in a prominent position for at least one month in case of stock in transit.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Co-Irbewin 300/12.5 mg, Tablets (Irbersatan &hydrochlorothiazide) and Irbewin 150 mg Tablets (irbersatan)
|
Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
|
Sanofi-Aventis South Africa, 2 Bond Street Grand Central Ext. 01 Midrand 1685. |
40/7.1.3/0287 |
AA550, AA507 |
August 2023 |
30 |
28 May 2020 |
Class II Type B |
27 October 2021 |
|
40/7.1.3/0288 |
AA406 |
September 2023 |
30 |
12 February 2021 |
Class II Type B |
27 October 2021 |
Reason for recall
These products are being recalled due to quality defect: Presence of impurity, also known as GTI 2 (5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole – CAS 152708-24-2) is formed during the manufacture of the active ingredient.
Advice to HCPs/Distributors/Public:
Stock is blocked for distribution and immediate quarantine of stock is initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Zartan Co 50/12,5 and Zartan Co 100/25 film coated Tablets (lorsatan potassium/ hydrochlorothiazide)
|
Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Pharma Dynamics (Pty) Ltd
Grapevine House, Steenberg Office Park, Silverwood, WestLake Cape Town South Africa |
42/7.1.3/1068, |
LC60922, LC60925, LC60717, LC60718, LC60716 |
August/2023 |
30 |
11 June 2021 |
Class II Type B |
15 September 2021 |
|
42/7.1.3/1069 |
LC60719, LC60721, LC60722 |
August/2023 | 30 | 02 July 2021 |
Class II Type B |
15 September 2021 |
Reason for recall
The products are being recalled due to quality defect: Presence of mutagesic azide impurity: The impurity, also known as known as 4-chloro azido methyl tetrazole, was detected during routine assessment and is formed during the manufacture of the active ingredient (API). The confirmed presence of a potential new azide impurity via their manufacturer was communicated to the API supplier (Zheijang Tianyu Pharmaceutical company).
Advice to HCPs/Distributors/Public:
As a precautionary measure all batches have been blocked for sale and immediate quarantine of stock is initiated in Distribution and Wholesales. Healthcare professionals are urged to return all inventory of ZARTAN CO 50/12,5 and ZARTAN CO 100/25 to their relevant distributor and/or wholesaler as soon as possible for reimbursement. Please retain this letter in a prominent position for at least one month in case of stock in transit.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Zyklot 75, tablets (clopidogrel)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Zydus Healthcare SA (Pty) Ltd, Southdowns Office Park, 22 Karee Street, Centurion, 0157, Pretoria
South Africa. |
A46/8.2/0972 |
M912323 AND M000240 |
31/07/2021(M912323) and 30/11/2021(M000240) |
30 |
12/11/2020 |
Class II Type B |
20 May 2021 |
Reason for recall
Austell Pharmaceuticals took the decision to initiate a voluntary recall on Azithromycin 200 mg/5 ml Powder for suspension. The recall is to be instituted due to some of the containers having defective primary packaging resulting in the seal being discoloured, which is not in line with the product specifications.
Advice to HCPs/Distributors/Public:
The company requested immediate return of all units on hand of the batches mentioned above to their supplying wholesaler or distributor for a full credit.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all distribution points, recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Adco-Napamol Tablets (paracetamol)
| Company name &
Address |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
|
Adcock Ingram limited – 1 New road, Midrand 1685, South Africa |
B/2.7/1404 |
AC1369, AC1373, AC1441, AC1430 |
07/2022; 08/2022 |
5000’s |
Dec 2020 |
Class II Type B |
13 July 2021 |
Reason for recall
The product was being recalled due to quality defect: Discoloration of tablets found in the batch.
Advice to HCPs/Distributors/Public:
The identified batches blocked for sale at Adcock Distribution centers and Hold Notification letter for Adco-Napamol tablets 5000’s was circulated to the Distributors and Wholesalers who bought directly from Adcock DCs. All stock of this batch must be immediately returned to your supplying wholesaler or distributor for full credit.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Panado 500mg Tablets (paracetamol)
| Company name &
Address |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
|
Adcock Ingram limited – 1 New road, Midrand 1685, South Africa |
B/2.8/858 |
AC1696 |
Sept-2022 |
24 |
11/2020 |
Class II Type B |
13 July 2021 |
Reason for recall
The product was being recalled due to quality defect: Discoloration of tablets found in the batch.
Advice to HCPs/Distributors/Public:
The identified batches blocked for sale at Adcock Distribution centers and Hold Notification letter for Adco-Napamol tablets 5000’s was circulated to the Distributors and Wholesalers who bought directly from Adcock DCs. All stock of this batch must be immediately returned to your supplying wholesaler or distributor for full credit.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Clonam 0.5 mg and Clonam 2 mg film coated Tablets (clonazepam)
|
Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
|
Ascendis Health Ltd 31 Georgian Crescent East Bryanston, South Africa |
0.5 mg: 45/2.5/0820 |
7862006-8 (3 batches) |
July-2022 |
84’s (Carton with Blister) |
12.July.2019 |
Class II Type B |
20 September 2021 |
|
2 mg: 45/2.5/0821 |
7872005-6 (2 batches) |
June-2022, July- 2022 |
84’s (Carton with Blister) |
12.July.2020 |
Class II Type B |
20 September 2021 |
*CLONAM 0.5mg and CLONAM 2 mg are both on state tender, code: RT289-2019, tender numbers: 51401516-00002 & 51401516-00001.
Reason for recall
The products are being recalled due to quality defect: the tablet description should be cross-scored, but instead the tablet has only a single score.
Advice to HCPs/Distributors/Public:
All remaining stock at distributor put in quarantine to avoid sale and to prevent further stock from being distributed. Customers/ health professionals were sent a recall letter and feedback was requested regarding quantity of stock on hand. Available stock at customers to be returned and placed in quarantine.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
ZAARIO 50 and ZAARIO 100 film coated Tablets (lorsatan potassium)
| Company name &
Address |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| UNICORN PHARMACEUTICALS (PTY) LTD
CNR SEARLE AND PONTAC STREETS, CAPE TOWN, 8001 |
50 mg: 46/7.1.3/0714 |
LS220001A |
July-2022 |
30 |
12/11/2020 |
Class II Type B |
31 August 2021 |
|
100 mg: 46/7.1.3/0715 |
LS320002A |
June-2022 |
30 |
30/11/2020 |
Class II Type B |
31 August 2021 |
Reason for recall
The products are being recalled due to quality defect: the presence of a mutagenic impurity above the threshold limit observed during analysis, as requested by the European Directorate for the Quality of Medicines and Healthcare (EDQM) on new Azido impurities [the presence of Azido (5-AMBBT) mutagesic impurity beyond total threshold limit was observed during analysis].
Advice to HCPs/Distributors/Public:
Stock is blocked for distribution and immediate quarantine of stock is initiated in Distribution and Wholesales. Quantity of stock affected to be confirmed. Return any of the above products to your United Pharmaceutical Distributor (UPD) wholesaler.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.
Champix 0,5 mg and 1,0 mg (varenicline) film coated Tablets - combo
| Company name &
Address |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton South
Africa |
41/34/0573- 41/34/0572 |
18069 |
31Aug-2021 |
Starter Pack 0.5mg/1mg Film Coated Tablet 1×11+3×14 |
12 Apr-2019 |
Class III Type B |
19 August 2021 |
Reason for recall
Following Test results that indicated levels of increased N-nitroso-varenicline that exceed the Acceptable Daily Intake (ADI) threshold of 733 ng/day calculated by Pfizer, based on ICH M7 guidance, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Champix, batch 18069 and notified SAHPRA Regulatory Compliance Units. Recall process: Recall letter distributed to all healthcare professionals via medpages.
Advice to HCPs/Distributors/Public:
The company requested the immediate return of all the affected batch of Champix to the supplying distributor for full credit without delay. As a precautionary measure, distribution remains on hold of all Distribution Points under Pfizer control
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.