Archive

14 May POLARx and POLARx FIT Cryoablation Catheters, POLARSHEATH Steerable Sheaths, and SMARTFREEZE Consoles

Posted at 19:06h in

Company name & Address: Material Description Material Number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Boston Scientific No. 8 Anslow Crescent Anslow Office Park Bryanston 2021 CRBS SMARTFREEZE CRYO Console M004CRBS4000 PXC00144 N/A Not available 18 August 2021 Class I Type C 06 May 2026 CRBS POLARX BALLOON CATHETER ST 28MM OUS M004CRBS2000 34158824 CRBS POLARX FIT BALLOON CATHETER ST OUS M004CRBS2010 33791785 CRBS POLARX FIT BALLOON...

13 May Aspelone (Prednisolone Sodium Phosphate)

Posted at 09:51h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Pharmacare Limited trading as Aspen Pharmacare Healthcare Park, Woodlands Drive, Woodmead, 2196 41/21.5.1/0189 E0023605 June 2027 50ml 15 October 2025 Class II Type B 08 May 2026 Brief description of the problem (reason for recall) This recall is initiated because incorrect labelling has been...

07 May Apixaban 2,5 DRL (Apixaban)

Posted at 11:12h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Dr Reddy’s Laboratories (Pty) Ltd Block C, Woodmead North Office Park, 54 Maxwell Drive, Woodmead, Sandton 56/8.2/0106 T2504569 August 2027 60’s 21 January 2026 Class II Type B 04 May 2026 Brief description of the problem (reason for recall) This recall is initiated due...

07 May Halaven (Eribulin)

Posted at 11:11h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Eisai Pharmaceuticals Africa (Pty) Ltd 2nd Floor, Golden Oak House, Ballyoaks Office Park, 35 Ballyclare Drive, Bryanston 48/26/0047 148482 May 2028 1 vial 06 December 2024 Class II Type C 04 May 2026 Brief description of the problem (reason for recall) This recall is initiated...

07 May OXOID™ Agglutinating Sera, Salmonella 9-0

Posted at 11:09h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Bioweb (Pty) Ltd Ridgeview Office Park 248 Kent Avenue Unit 10 Randburg 2194 N/A 6253410 02 June 2028 2ml Not available Class III Type C 04 May 2026 Brief description of the problem (reason for recall) This recall has been initiated following an internal technical investigation, which determined...

04 May Ciprofloxacin 250 MG Austell (Ciprofloxacin Hydrochloride)

Posted at 16:15h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Austell Pharmaceuticals (Pty) Ltd 1 Sherborne Road, Parktown, Johannesburg 38/20.1.1/0011 AEW014001 31 January 2028 10 Tablets 05 July 2024 Class III Type C 24 April 2026 Brief description of the problem (reason for recall) This recall is initiated due to: The inclusion of an...

04 May Report for Monitoring and Advertising of Promotional Material

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 Cipla-Pioglitazone Hydrochloride 15 (Pioglitazone Hydrochloride)

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 Visipaque (Iodixanol)

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 Omnipaque (Iohexol anhydrous)

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...