Archive

27 Apr PROTA 50 mg/ 5 ml (Protamine Sulphate – Ampoules for IV injection)

Posted at 12:56h in

PROTA 50 mg/ 5 ml (Protamine Sulphate - Ampoules for IV injection) Company name & Address registration number Batch number Expiry date Pack size First distributed Re-call Classification Re-call Date Equity Pharmaceutica ls (Pty) Ltd, 100 Sovereign Drive, Route 21 Corporate park, Irene, Pretoria, South Africa, 0157 N/A (Section 21, Unregistered) IPTAA1203 31.12.2023 25’s 11/2020 Class II Type B 26 May 2022 Reason...

27 Apr Lactulose concentrate API (Lactulose Concentrate solution- 66% and 70% )nsoprazole)

Posted at 12:55h in

Manufacturer name & Address Customers Batch number Manufacturing Date Expiry dates Batch release date Quantity dispatched to customer Re-call Classification Re-call Date Lacsa (Pty) Limited 72 Ballantrae Road, Merebank, Durban, South Africa Pharmchem Lab P3915 17.Sept.2021 11Aug-2025 24.Aug.2021 840 kg Class II Type B 18 May 2022 Relax Limited P3822, P3823, P3841, P3912,P3913 P3915, P3916,P3919, 11.Jan.2021, 13.Jan.2021, 31.Oct.2020, 07.Aug.2021, 11.Aug.2021 10.Jan.2025, 13.Jan.2025 31.Oct.2024 07.Aug.2025 13.Aug.2025 25.Jan.2021 08.Feb.2021 11.Mar.2021 30.Aug.2021 24.Aug.2021 696 060 kg Class II Type B 18 May 2022 Reason for recall The product was being recalled due to quality defect:The product was found to have microbial counts...

27 Apr Lancap 15mg capsules (Lansoprazole)

Posted at 12:54h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First date of release Re-call Classification Recall date Pharma Dynamics (Pty) Ltd Floor 1, Grapevine House. Steenberg Office park, Silverwood close, Westlake, Cape Town, South Africa 7945 A40/11.4.3/0247 SJ2758 SJ3425 SJ2652 SJ8693 Mar 2024 Nov 2023 Mar 2024 Aug 2024 14’s 10.Sep.2021 22.Sept.2021 13.Sept.2021 15.Mar.2022 Class III Type C 12.Sep.2022 Reason for recall This recall is initiated due to...

27 Apr Oranix Solution (oral rinse) (Benzydamine HCl 22,5 mg/15 ml; Chlorhexidine gluconate 18,0 mg/15 ml)

Posted at 12:53h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Re-call Date iNova Pharmaceuticals (Pty) Ltd 15E Riley Road, Bedfordview, 2007 South Africa 34/16.4/0391 126189 11/2023 200 ml 13.12.2021 Class III Type C 28 January 2022 Reason for recall This product is being recalled due to a complaint relating to quality defect: The assay of the active pharmaceutical ingredient, chlorhexidine gluconate, is...

27 Apr OsvaRen 435mg_235 film coated tablets

Posted at 12:52h in

OsvaRen 435mg_235 film coated tablets Company name & Address: registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Re-call Date Fresenius Medical Care South Africa (PTY) Ltd. 9 Galaxy Ave. Frankenwald Sandton 2090, South Africa 45/24/0919 ZC015 200, ZOAK08100, ZOAK04 200, ZC016100, ZOAK04300, ZOAK05200, ZOAK08300 2.2021 (old), 30.07.2022 (new) 9.2021 (old), 31.07.2022 (new) 2.2021 (old),12.20 21 (new) 180s 04/10/2019 Class III Type B 22 April 2022 Reason...

27 Apr DERMADINE ORAL ANTISEPTIC solution (Povidone-iodine 1,00 g (1 % m/v))

Posted at 12:52h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Re-call Date Cipla Medpro (Pty) Ltd, Cipla Head Office, Parc du Cap, Building 9, Mispel Street, Bellville, Bellville,Cape Town, 7530, South Africa H1511 (Act 101/1965) 120983 October 2022 200 ml September /2020 Class III Type C 24 January 2022 Reason for recall This product is being recalled due...

27 Apr Azacitidine DRL 100mg Lyophilized powder for Injection (Azacitidine)

Posted at 12:50h in

Company name & Address: registration number Batch number Expiry date Pack size First distributed Re-call Classification Re-call Date Dr. Reddy’s Laboratories Limited, Chemical Technical Operations, Unit- I, Plot No. 137,138, 145 & 146 51/26/0144 H210418 Mar/2023 Vial: 30ml 2021/10/06 Class III Type C 11 January 2022 Reason for recall The products are being recalled due to quality defect: The company initiates an immediate recall...

27 Apr LOSAAR PLUS 50/12.5 TABLETS 30’S (losartan 50 mg, hydrochlorothiazide 12,5 mg) and LOSAAR PLUS 100/25 TABLETS 30’S (losartan 100 mg, hydrochlorothiazide 25 mg)

Posted at 12:49h in

Company name & Address: registration number Batch number Expiry date Pack size First distributed Re-call Classification Re-call Date Accord Healthcare (Pty) Ltd, Building 2, Tuscany Office Park 6 Coombe Place, Johannesburg, South Africa 50/12.5mg: 42/7.1.3/0325 01523, 000919, 000920, 01870 May 2023 Jul 2023 30 July 2020 Class II Type B 6 October 2021 100/25 mg: 46/7.1.3/0715 00915, 00916, 00917, 00918 May-2023 30 July 2020 Class II Type B 6 October 2021 Reason for recall The products are being recalled due to...

27 Apr Co-Irbewin 300/12.5 mg, Tablets (Irbersatan &hydrochlorothiazide) and Irbewin 150 mg Tablets (irbersatan)

Posted at 12:48h in

Company name & Address: registration number Batch number Expiry date Pack size First distributed Re-call Classification Re-call Date Sanofi-Aventis South Africa, 2 Bond Street Grand Central Ext. 01 Midrand 1685. 40/7.1.3/0287 AA550, AA507 August 2023 30 28 May 2020 Class II Type B 27 October 2021 40/7.1.3/0288 AA406 September 2023 30 12 February 2021 Class II Type B 27 October 2021 Reason for recall These products are being recalled due to...

27 Apr Zartan Co 50/12,5 and Zartan Co 100/25 film coated Tablets (lorsatan potassium/ hydrochlorothiazide)

Posted at 12:47h in

Company name & Address: registration number Batch number Expiry date Pack size First distributed Re-call Classification Re-call Date Pharma Dynamics (Pty) Ltd Grapevine House, Steenberg Office Park, Silverwood, WestLake Cape Town South Africa 42/7.1.3/1068, LC60922, LC60925, LC60717, LC60718, LC60716 August/2023 30 11 June 2021 Class II Type B 15 September 2021 42/7.1.3/1069 LC60719, LC60721, LC60722 August/2023 30 02 July 2021 Class II Type B 15 September 2021 Reason for recall The products are being recalled due to quality defect:...