Archive

27 Apr Gastrografin (Meglumine amidotrizoate + Sodium amidotrizoate solution 0.76 g/mL)

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 Sereflo 25/125 HFA

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...

27 Apr Flucloxacillin 250 Capsules (Flucloxacillin 250 Oethmaan)

Posted at 16:26h in

Company name & Address: registration number Batch (Bulk) number(s) Expiry date Pack size First distributed Re-call Classification Recall date Oethmaan Biosims (Pty) Ltd 07A Sherwood House Greenacres Office Park Corner of Victory and Rustenburg Roads Victory Park Johannesburg. Gauteng 2195 South Africa 44/20.1.2/0816 MP25071 MP25072 MP25073 MP25151 MP25152 MP25224 MP25225 MP25257 12/2026 12/2025 01/2027 02/2027 02/2027 02/2027 02/2027 03/2027 40’s 40’s 20’s 40’s 40’s 40’s 40’s 20’s 14/05/2025 02/06/2025 03/04/2025 23/06/2025 17/07/2025 23/07/2025 14/08/2025 15/08/2025 Class II Type C 18. December.2025 Brief description of the problem (reason for recall) The recall is initiated because Oethmaan Biosims...

27 Apr Sodium Fluoride 0.55mg/4 drops equivalent to 0,25 mg fluoride. (Zymafluor Oral Drops)

Posted at 16:25h in

Company name & Address: Registration number Batch (Bulk) number(s) Expiry date Pack size First distributed Re-call Classification Recall date Viatris South Africa (Pty) Ltd 4 Brewery Street Isando, Johannesburg, 1609 Y/24/394 2304254 30 June 2028 20 ml 28 November 2023 Class II Type B 19. December.2025 Brief description of the problem (reason for recall) Incomplete closure due to insufficient cap sealing, resulting in damage to...

27 Apr Ondansetron HCL 8mg tablet (Zothena 8 mg)

Posted at 16:24h in

Company name & Address: registration number Batch (Bulk) number(s) Expiry date Pack size First distributed Re-call Classification Recall date Eurolab (Pty) Ltd Woodmead Office Park 3 Stirrup Lane Van Reenens Avenue Woodmead 2144 South Africa 52/5.10/1011 2430701 30/11/2027 10’s 14 April 2025 Class II Type B 02.December .2025 Brief description of the problem (reason for recall) This recall is initiated following the discovery of Zothena 4 mg cartons...

27 Apr Metronidazole 400mg tablet (Bemetrazole 400mg)

Posted at 16:24h in

Company name & Address: Registration number Batch (Bulk) number(s) Expiry date Pack size First distributed Re-call Classification Recall date Ranbaxy Pharmaceuticals (Pty) Ltd 14 Lautre Road Stormill Extension 1 Roodepoort Johannesburg Gauteng 1724 South Africa X/20.2.6/84 BTF1332A 10/2026 500’s 30 January 2025 Class II Type B 28.November .2025 Brief description of the problem (reason for recall) This recall is initiated due to discolouration of tablets. Based on micro testing,...

27 Apr Ondansetron HCL 4mg tablet (Zothena 4 mg)

Posted at 16:23h in

Company name & Address: registration number Batch (Bulk) number(s) Expiry date Pack size First distributed Re-call Classification Recall date Eurolab (Pty) Ltd Woodmead Office Park 3 Stirrup Lane Van Reenens Avenue Woodmead 2144 South Africa 52/5.10/1010 2430601 30/11/2027 10’s 01/04/2025 Class II Type B 02.December .2025 Brief description of the problem (reason for recall) This recall is initiated following the discovery of Zothena 4 mg cartons containing Zothena...

27 Apr ATRACURIUM BESILATE 10mg/ml Ampoule for Injection (Tracrium (10mg/ml))

Posted at 16:22h in

Company name & Address: registration number Batch (Bulk) number(s) Expiry date Pack size First distributed Re-call Classification Recall date Aspen SA Sterile Operations (Pty) Ltd 8B Gibaud Road Korsten Gqeberha Eastern Cape 6020 South Africa R/17.1/210 XP1W5 (301910) 30/11/2026 5’s May 2025 Class I Type B 26.November .2025 Brief description of the problem (reason for recall) This recall is initiated because of the potential serious risk following detected glass...

27 Apr CISATRACURIUM BESYLATE 2mg/ml Ampoule for Injection (Nimbex (2mg/ml))

Posted at 16:21h in

Company name & Address: registration number Batch (Bulk) number(s) Expiry date Pack size First distributed Re-call Classification Recall date Aspen SA Sterile Operations (Pty) Ltd 8B Gibaud Road Korsten Gqeberha Eastern Cape 6020 South Africa 31/17.1/0444 (5 ml) 31/17.1/0445 (10 ml) XP1YM (301940) XPC4M (301950) 31/10/2026 30/09/2026 5’s 5’s May 2025 Jul 2025 Class I Type B 26.November .2025 Brief description of the problem (reason for recall) This recall is initiated because of the potential...

27 Apr MIVACURIUM CHLORIDE 10mg/5ml Ampoule for Injection (Mivacron (10mg/5ml))