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27 Apr

Posted at 12:47h in

  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:...

27 Apr

Posted at 12:46h in

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...

27 Apr

Posted at 12:45h in

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...

27 Apr

Posted at 12:44h in

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...

27 Apr

Posted at 12:42h in

  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...

27 Apr

Posted at 12:41h in

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...

27 Apr

Posted at 12:39h in

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...

25 Mar

Posted at 11:24h in

This communication is intended to inform the relevant GDP license holders of the one-time renewal of expired GDP resolution letters. SAHPRA is introducing this initiative as a targeted measure to strengthen compliance management while addressing operational challenges.   Frequently Asked Questions (FAQ): One-Time Renewal of Expired GDP...

18 Dec

Posted at 08:27h in

With reference to the communication issued on 30 June 2025 (HPA05-2025/26, Version 5), SAHPRA wishes to inform all holders of certificates of registration that the current predefined submission window for Type II variation applications (including related changes bundled variation submissions) within the period 02 January...