Archive

27 Apr JANUMET 50/850mg and JANUMET 50/1000mg (50mg of Sitagliptin with 850mg of Metformin Hydrochloride AND 50mg of Sitagliptin with 1000mg of Metformin Hydrochloride)

Posted at 13:00h in

Company name & Address: Product registration number Batch number(s) Expiry date(s) Pack size Re-call Classification Recall date 117, 16th Road, Midrand, South AfricaPrivate Bag 3, Halfway House, 1685 JANUMET 50/850mg 42/21.2/1090 W01552 W01553 2023/10/31 2023/10/31 2023/10/31 28s 28s 2022/07/06 2022/07/18 Class III Type C 05.Sept.2022 JANUMET 50/1000mg 42/21.2/1091 W015798 2023/11/30 28s 2022/07/18 Class III Type C 05.Sept.2022 W015803 2023/11/30 28s 2022/07/06 W017752 2023/11/30 28s 2022/07/27 W018077 2023/11/30 28s 2022/08/02 W021662 2024/01/31 28s 2022/08/12 Reason for recall The products are being re-called due to quality defect; the company initiated...

27 Apr Rocephin 1G injection (1 vial with dry substance equivalent to 1g ceftriaxone + 1 ampoule water for injection 10ml)

Posted at 12:59h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Re-call Date Roche products (Pty) LtdBuilding E, Hertford Office Park90 Bekker Road, Midrand 1686 R/20.1.1/46 B0757B04 31-03-2024 1 Mar-2021 Class I Type C 1 July 2022 Reason for recall The products are being recalled due to quality defect: Pinholes were found on the 10ml Water for...

27 Apr Adco-Napacod tablets (Paracetamol 500 mg and Codeine Phosphate 10mg)

Posted at 12:58h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Re-call Date Adcock Ingram Limited. 1 New Road, Midrand, 1685 B/2.8/1401 AD0433 AC1264 02-2026 06-2025 1000’s 25 June-2021 08 Oct-2020 Class II Type B 23 June 2022 Reason for recall The products are being recalled due to quality defect: the company received customer complaints reporting discoloration of tablets and/or...

27 Apr Coryx Throat Spray (Benzocaine and chlorhexidine gluconate solution 20 %)

Posted at 12:58h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First date of release Re-call Classification Re-call Date Cipla Medpro (Pty) Ltd Parc du Cap Building 9 Mispel Street Bellville 7530 Telephone number (021) 94 W/16.3/58 ZB000156, ZB000157, ZB000158, ZB000159, ZB000160, ZB100105, ZB100107 ZB100172 10.2022 10.2022 10.2022 10.2022 10.2022 02.2023 02.2023 03.2023 100 ml 04.02.2021 04.02.2021 09.02.2021 09.02.2021 09.02.2021 14 & 15.06.2021 21. 06.2021 Class I Type A 15 June 2022 Reason for recall Cipla Medpro (Pty) Ltd, in collaboration with SAHPRA, is recalling the above-mentioned batches...

27 Apr Demetrin 10mg (prazepam)

Posted at 12:57h in

Company name & Address Registration number Batch number Expiry date Pack size First distributed Re-call Classification Re-call Date Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton South Africa G/2.6/188 DT3236 28 Feb-2023 100’s 21 July-2020 Class II Type B 4 July 2022 Reason for recall The recall is due to out of specification results for dissolution during stability studies,...

27 Apr Accumax 10mg and 20 mg Film Coated Tablet (QUINAPRIL HYDROCHLORIDE)

Posted at 12:56h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Re-call Date Pfizer Laboratories (Pty) Ltd 85 Bute Lane, Sandton, South Africa 34/7.1.3/0230 CK8048, DC6880 and DM5063 28/02/2022 30s 10 mg 19-Oct-2019 30-Mar-2020 10-Jun-2020 Class II Type B 25 April 2022 Pfizer Laboratories (Pty) Ltd 85 Bute Lane, Sandton, South Africa 34/7.1.3/0231 DM5060, EA7796 and, 31/12/2022 30s 20 mg 20-May-20, 28-Sep-20 24-Jan-20 Class II Type B 25 April 2022 AW1957, CM2638 28/02/2022 24-Jan-20 Reason for...

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...