Archive

19 Aug Percutaneous Insertion Kits 100 and 150 (PIK)

Posted at 08:48h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Surgical Innovation Pty Ltd Stand 208C Hoogland Ext 44 Cnr Apsom Avenue and Malibongwe Drive Boundary Park Northriding Randburg 2169 N/A 04037691519883 04037691730660 04037691519876 04037691730677 04037691746500 04037691746517 N/A 1 set April 2021 Class II Type B 12 August 2026 Brief description of the problem (reason for recall) Maquet Cardiopulmonary GmbH the Original Equipment Manufacturer (OEM)...

18 Aug Frusemide 20 mg/2 ml Fresenius (Furosemide)

Posted at 08:46h in

Company name & Address: Registration number Batch number(s) Registered Expiry Date (Labelled Expiry Date) Pack size First release date Re-call Classification Recall date Fresenius Kabi South Africa (Pty) Ltd 7 Kingfisher Avenue Midpoint 162 Tonetti Street Halfway House Ext. 7, Midrand Gauteng, 1685 PO Box 4156 Halfway House Gauteng, 1685 K/18.1/207 90TEA870 90TIA300 90TKB190 90TLA480 90UCA000 90UEA840 90UIA510 90UIA530 90WEA230 30 April 2027 (30 April 2029) 31 August 2027 (31 August 2029) 30...

13 Aug Guideline for Health Product Traceability: Update on Implementation

Posted at 15:24h in

As part of implementing the Traceability Guideline on Health Products, the South African Health Products Regulatory Authority (SAHPRA)continues to engage with industry stakeholders, sector associations, and public-sector partners as the project moves from planning phase to delivery. An important part of this work is the survey...

13 Aug ZS70658 – VAC TUBE CLOT ACTIV+GEL SEP 5mL (2 4mL)

Posted at 13:59h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Gen Analytica 54 Maxwell Drive North Office Park Block B Suite 34 Woodmead N/A A10015 A10016 N/A 1 set 22 April 2026 Class II Type B 12 August 2026 Brief description of the problem (reason for recall) This recall is initiated due to customer complaints received reporting potassium...

12 Aug Smart Bag Flexpack Acid Concentrates

Posted at 13:37h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Fresenius Medical Care – South Africa 9 Galaxy Road Linbro Park Sandton Johannesburg. N/A See Recall letter See Recall letter 1’s 2025/10/20 Class I Type B 07 August 2026 Brief description of the problem (reason for recall) The recall is being initiated as the distributor for certain...

12 Aug General Regulations Made in Terms of the Medicines and Related Substances Act 101 of 1965: Amendment to Regulation 6: Notice of Correction

Posted at 11:43h in

The South African Health Products Regulatory Authority (SAHPRA) wishes to inform all pharmaceutical industry stakeholders that an amendment to Regulation 6 was published in Government Gazette No. 55152, Notice No. 7780, on 7 August 2026 for implementation. The published amendment contained two aspects: first, the...

02 Aug Enalapril 10mg Arya

Posted at 21:05h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Arya Pharma Pty Ltd Pharma HQ, Corner Barbara and North Reef Road, Elandsfontein, Germiston, Gauteng, 1601. 37/7.1.3/0328 GQQ24066 GQQ24064 GQQ24067 GQQ24053 GQQ24066 (Sep-2026) GQQ24064 (Sep-2026) GQQ24067 (Sep-2026) GQQ24053 (Aug-2026) 28’s GQQ24066 (Jan-2025) GQQ24064 (Jan-2025) GQQ24067 (July-2025) GQQ24053 (Jan-2025) Class II Type A 29 July 2026 Brief description of the problem (reason for recall) Quality defect: This recall...

23 Jul Nintedanib 100 mg Cipla and Nintedanib 150 mg Cipla

Posted at 11:33h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Cipla Medpro (Pty) Ltd. Building 2 Junxion Park 10 Elephant Lane Century City South Africa 7441 56/26/0704.702 56/26/0705.703 6KA0781 6KA0782 01.2028 01.2028 60’s 14.04.2026 14.04.2026 Class II Type B 21 July 2026 Brief description of the problem (reason for recall) This recall is initiated as a result of product quality...

23 Jul Homechoice Automated PD set with cassette and 4-Prong luers

Posted at 11:31h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Adcock Ingram Critical Care 1 Sabax Road Aeroton Johannesburg 2013 South Africa N/A 25L02T005 25L06T017 26A02T005 25L02T005 (NOV 2030) 25L06T017 (NOV 2030) 26A02T005 (DEC 2030) 1’s 25L02T005(21 APR 2026) 25L06T017 (09 APR 2026) 26A02T005 (22 APR 2026) Class III Type C 20 July 2026 Brief description of the problem (reason for recall) Adcock Ingram...

23 Jul Evo Aqueous Cream BP 500g

Posted at 11:27h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Evohealth (Pty) Ltd 11 Jacaranda Street Lords View Industrial Park Offices Chloorkop Midrand 1619 N/A 030 44 10/25 October 2027 500g 20 October 2025 Class II Type B 17 July 2026 Brief description of the problem (reason for recall) This recall is initiated as a result of a...