Regulatory Compliance Archives - Page 5 of 18 - SAHPRA

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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...

Company name & Address: Product Name(s) registration 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     CSK TC ELECTRODE 10CM   N/A   All   Not available   Not available   Not available   Class II Type B   14 May 2026 CSK 10CM TC ELECTRODE WITH 3M CABLE CSK TC ELECTRODE 15CM CSK 15CM TC ELECTRODE WITH 3M CABLE CSK...

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date ZimmerBiomet S. A.Pty Ltd 2 Bridal Veil Road Waterfall DistributionCampus 2066   N/A       82395238 82395239 82395240 85390022 85390023 85390024 85390025 85390026 85390027 85390028 85390029 85682882 86970970   Not Available   20 pack   August 2025   Class II Type C   14 May 2026   Brief description of the problem (reason for recall) This recall has been initiated issue is related to...

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...

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...

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...

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...

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...

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...

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...