Archive

27 Apr Monofer 500mg/5ml (Iron (III) isomaltoside)

Posted at 13:27h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Recall date Date Published Acino Pharma (Pty) Ltd, No 106, 16th Road, Midrand, 1686, Gauteng, South Africa 46/8.3/0167 230504A-5 May 2026 5ml (5 vials per carton) 16 May 2024 Class III Type B 16 September 2024 14 October 2024 Reason for recalls This recall is initiated as a...

27 Apr Zinium Infant Drops

Posted at 13:26h in

Company name & Address: 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 N/A (Category D Product) 5890 5943 6981 February 2025 March 2025 October 2025 30 ml 31 March 2023 14 August 2023 12 March 2024 Class III Type B 03 September 2024 Reason for recalls This recall is initiated as a potential quality...

27 Apr Dovate Cream (Clobetasol Propionate)

Posted at 13:25h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Recall date Pharmacare Ltd t/a Aspen Pharmacare Building 12, Healthcare Park Woodlands Drive 27/13.4.1/0316 E0012547 April 2026 25g 12 June 2024 Class III Type B 29 August 2024 Reason for recalls This recall is initiated because of the compromised package integrity on some of the tubes....

27 Apr Coralan 7.5 mg Tablets (Ivabradine 7.5mg)

Posted at 13:25h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Recall date Servier (Pty) Ltd 3rd Floor, Building J, Hertford Office Park, 90 Bekker Road, Vorna Valley, Midrand, 1686 A39/7.1.4/0411 719715 709702 705182 701085 705921 715957 697702 January 2026 April 2025 April 2025 March 2025 April 2025 November 2025 December 2024 56’s 20 April 2024 22 March 2023 22 March 2023 02 September 2022 22 March 2023 27 July...

27 Apr Deplatt Tablets (Clopidogrel 75 mg)

Posted at 13:24h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Recall date Trinity Pharma (Pty) Ltd, 3 Gwen Lane Fourth Floor Sandton 45/8.2/1031 BT40J001 December 2023 30’s 28 June 2022 Class II Type C 02 November 2023 Reason for recalls This recall is initiated due to an out of specification result for the assay test at...

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...