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04 May

Posted at 16:11h in

The Regulatory Compliance Unit of the South African Health Products Regulatory Authority (SAHPRA) is mandated to ensure that the marketing and promotion of medicines, scheduled substances, medical devices, and in vitro diagnostic medical devices (IVDs), for both human and veterinary use, comply with the Medicines...

30 Apr

Posted at 10:03h 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   A40/21.2/0149   4GC0350 GC30719   February 2027 July 2026   30s   06 August 2024 30 November 2023   Class II Type B   20.April.2026   Brief description of the problem (reason for recall) This recall is initiated because of a dissolution failure...

30 Apr

Posted at 10:01h in

Company name & Address: Product strength registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Ge Healthcare (Pty) Ltd Office Suite BOG Ground Floor Level, Building B Stoneridge Office Park 8 Greenstone Place, Greenstone Hill Johannesburg, Gauteng South Africa, 1609 Visipaque 320 mg/ml 100 ml   31/28/0177   17244629   August 2028     100 ml   12 December 2025     Class II Type B   20.April.2026   Brief description of the...

30 Apr

Posted at 10:00h in

Company name & Address: Product strength registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Ge Healthcare (Pty) Ltd Office Suite BOG Ground Floor Level, Building B Stoneridge Office Park 8 Greenstone Place, Greenstone Hill Johannesburg, Gauteng South Africa, 1609 Omnipaque 300 mg/100 ml   X/28/80   17262906 17314099   August 2028 August 2028   100 ml   12 December 2025 12 December 2025   Class II Type B   20.April.2026 Omnipaque 350...

28 Apr

Posted at 17:03h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Pharmaco Distribution 91 Protea Road Chislehurston Sandton 2196     N/A       251485     23 October 2027     1 sterile unit per pack     22 December 2025     Class I Type B     17.April.2026 This recall is being conducted due to a manufacturing defect that may result in breakage of the handle...

27 Apr

Posted at 16:38h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Adcock Ingram Limited 1 New Road, Midrand, 1685   E1031   See Recall Letter   See Recall Letter   60g 120g 4g x 30 Sachets   See Recall Letter   Class II Type A   17.Mar.2026   Brief description of the problem (reason for recall) The recall follows the identification of potential foreign material...

27 Apr

Posted at 16:37h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Glenmark Pharmaceuticals South Africa (Pty) Ltd 2nd Floor, Building D, Stoneridge Office Park, 8 Greenstone Place, Greenstone, Edenvale, Gauteng, 1609   43/20.1.6/0680   19242129   30 April 2026   50g   30 Aug 2024   Class II Type B   10.Mar.2026 Brief description of the problem (reason for recall) This recall...

27 Apr

Posted at 16:37h in

Company name & Address: Product strength 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   Urografin 30% F/28/0606 MA04VPS MA04V7D  MA04SJ4 30/04/2030 30/04/2030 30/09/2029 250 ml June 2025   Class II Type B 06.Mar.2026   Urografin 60%   H/28/2843   MA04R29   31/08/2029   250 ml   June 2025     Class II Type B   06.Mar.2026   Urografin 76%   H/28/2844   MA04SRF MA04X07   30/09/2029 30/09/2029   250 ml   June 2025   Class II Type...

27 Apr

Posted at 16:36h in

Brief description of the problem (reason for recall) Bayer has detected a risk for the formation of nitrosamine (N-Nitroso-Meglumine) in Gastrografin/Urografin. The evaluation of N-Nitroso-Meglumine showed a potential of mutagenicity in a mouse All formulations of meglumine amidotrizoate and sodium amidotrizoate (Gastrografin, Urografin) are exceeding the...

27 Apr

Posted at 16:35h in

Company name & Address: registration number Batch (Bulk) number(s) Expiry date Pack size First distributed Re-call Classification Recall date Cipla Medpro (Pty) Ltd Building 2 Junxion Park 10 Elephant Lane Century City South Africa 7441 42/21.5.4/0219 5IB0093 November 2026 1 unit 07 March 2025   Class III Type C 30.Jan.2026 Brief description of the problem (reason for recall) This recall is initiated due to an out of specification result in...