Archive

27 Apr Acenten 20/12,5 mg Tablets (Enalapril Maleate 20 mg and Hydrochlorothiazide 12.5mg)

Posted at 13:23h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Recall date Austell Pharmaceuticals 1 Sherborne Road Parktown 2193 49/7.1.3/1087 JTU022001 JTU022002 11/2024 30’s 29 March 2023 Class II Type B 10 January 2024 Reason for recalls The product is being recalled due to a noted out of specification which may result in sub-therapeutic dosing. Advice to HCPs/Distributors/Public Further...

27 Apr Berocca Performance Mango Tablets

Posted at 13:22h in

Berocca Performance Mango Tablets Company name & Address: Product Registration number Batch number(s) Expiry date Pack size Re-call Classification Recall date Bayer (Proprietary) Ltd Regulatory Affairs, Pharmaceuticals 27 Wrench Road, Isando, 1600 Berocca Mango VAPS Berocca Mango VAPS Berocca Mango 30’s D540604 (Category D Product) 43782 43783 43384 July 2025 45’s 45’s 30’s Class III Type C 28 November 2023 Reason for recalls Identified black particles in the Berocca Mango...

27 Apr Emistop 4 mg (Ondansetron 4 mg)

Posted at 13:22h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First distribution Re-call Classification Recall date Pharma Dynamics (Pty) Ltd, 1st Floor, Grapevine House, Steenberg Office Park, Silwerwood Close, Westlake, Cape Town, 7945 45/5.10/0386 B5G0138A April 2026 Five ampoules packed in an outer carton 18 August 2023 Class II Type B June 2024 Reason for recalls Elevated levels of an...

27 Apr NEXIPRAZ IV (Esomeprazole 40mg)

Posted at 13:21h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Recall date Ranbaxy Pharmaceuticals (Pty) Ltd 14 Lautre Road, Stormill Extension 1 Roodepoort 46/11.4.3/0606 HAE3136A May 2025 10’s 31 May 2024 Class III Type C 08 July 2024 Reason for recalls The recall is initiated because an out of specification result observed in the TAMC test...

27 Apr ZINERYT LOTION (Erythromycin 40 mg/ml and Zinc acetate 12 mg/ml)

Posted at 13:20h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First date of release Re-call Classification Recall date Adcock Ingram Limited 1 New Road, Midrand, 1685 34/13.12/0474 66869 September 2024 30ml 16 August 2022 (initial batch) 11 March 2024 (rework batch) Class II Type B 04 July 2024 Reason for recalls The recall is initiated because there has been peroxide detected in...

27 Apr Ketamine 50 mg/1 ml Fresenius (Ketamine Hydrochloride)

Posted at 13:20h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Recall date Fresenius Kabi Manufacturing South Africa (Pty) Ltd. 6 Gibaud Road, Korsten, Gqeberha, 6020, South Africa Y/2.1/273 90SKB230 September 2027 10 units per carton 21 December 2023 Class II Type C 14 June 2024 Reason for recalls This precautionary recall is initiated due to potential...

27 Apr Zinium Junior Diabetic Friendly Syrup and Zinium Junior Syrup

Posted at 13:19h in

Company name & Address: Product Registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Recall date iNova Pharmaceuticals (Pty) Ltd, 15E Riley Road, Bedfordview, 2007 Zinium Junior Diabetic Friendly Syrup N/A (Category D product) 5661 5521 5958 5322 December 2024 October 2024 March 2025 August 2024 200ml 10 February 2023 24 May 2023 24 June 2023 26 June 2023 Class III Type C 24 April 2024 Zinium Junior Syrup N/A (Category D...

27 Apr Resmed Elemental Zinc Syrup (Elemental Zinc 10mg/5 ml)

Posted at 13:18h in

Company name & Address Registration number Batch number Expiry date Size First distributed Re-call Classification Recall date RESMED HEALTHCARE, 71 Rochdale Road, Springfield Park, Durban, 4051 E0833 All batches All batches 150 ml Class III Type C 05 December 2023 Reason for recalls It has come to our attention that the...

27 Apr Histagex syrup (Chlorphenamine maleate 2mg/5 ml)

Posted at 13:18h in

Company name & Address Registration number Batch number Expiry date Size First distributed Re-call Classification Recall date RESMED HEALTHCARE, 71 Rochdale Road, Springfield Park, Durban, 4051 E765 All batches All batches 50 ml Class III Type C 05 December 2023 Reason for recalls It has come to our attention that the...

27 Apr Benylin Paediatric Syrup (each 5 ml contains 7 mg Diphenhydramine HCl)

Posted at 13:17h in

Company name & Address Registration number Batch number Expiry date Size First distributed Re-call Classification Recall date 241 Main Road, Retreat 7945, Cape Town, South Africa H/10.1/12 329303 April 2024 100ml glass bottle 11 June 2021 Class I Type A 11 Apr 2024 Reason for recalls On 10 April 2024, the South African Health Products Regulatory Authority (SAHPRA) received...