Archive

19 May Pepta AC Gel (Magnesium Carbonate light, Magnesium Trisilicate, Sodium bicarbonate)

Posted at 15:09h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Asante Pharma 15 Cleeve Road Henley on klip Gauteng N/A B250515 B260383 B260382 B250514 February 2027 October 2027 October 2027 February 2027 200ml 06 October 2025 Class III Type C 14 May 2026 Brief description of the problem (reason for recall) This recall is initiated due to the contravention of Section 14...

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 Bioequivalence studies performed by Contract Research Organisation (Raptim Research Pvt. Ltd)

Posted at 18:49h in

This document is intended to communicate the South African Health Products Regulatory Authority’s (SAHPRA’s) position to all Applicants/ Holders of Certificates of Registration (HCRs) who intend to submit/ have submitted applications supported by bioequivalence studies conducted by Raptim Research Pvt. Ltd, a Contract Research Organisation...

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...

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...

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...

27 Apr Citro-Soda (Sodium bicarbonate, Tartaric acid, Citric acid, Sodium citrate)

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...