Regulatory Compliance Archives - Page 3 of 18 - SAHPRA

Archive

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...

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...

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...

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...

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...

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...

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...

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...

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Haleon South Africa (Pty) Ltd 11 Hawkins Avenue Epping Industria 1 Cape Town South Africa 7460     Y/11.4/185   V79A   31 December 2029   72 Sachets   23 March 2026   Class III Type C   17 July 2026     Brief description of the problem (reason for recall) Quality defect: Faulty packaging: Units containing sachets...