Archive

27 Apr Co-Irbewin 300/12.5 mg, Tablets (Irbersatan &hydrochlorothiazide) and Irbewin 150 mg Tablets (irbersatan)

Posted at 12:48h in

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...

27 Apr Zartan Co 50/12,5 and Zartan Co 100/25 film coated Tablets (lorsatan potassium/ hydrochlorothiazide)

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 Zyklot 75, tablets (clopidogrel)

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 Adco-Napamol Tablets (paracetamol)

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 Panado 500mg Tablets (paracetamol)

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 Clonam 0.5 mg and Clonam 2 mg film coated Tablets (clonazepam)

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 ZAARIO 50 and ZAARIO 100 film coated Tablets (lorsatan potassium)

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 Champix 0,5 mg and 1,0 mg (varenicline) film coated Tablets – combo

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 Once-off Renewal of Expired Resolution Letters for Low-risk GDP Sahpra Pharma Licensed Sites One-time Renewal of Expired Gdp Resolution Letters

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 Variations Communication

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...