27 Apr Metronidazole 400mg tablet (Bemetrazole 400mg)
| Company name & Address: | Registration number | Batch (Bulk) number(s) | Expiry date | Pack size | First distributed | Re-call Classification | Recall date |
|
Ranbaxy Pharmaceuticals (Pty) Ltd 14 Lautre Road Stormill Extension 1 Johannesburg Gauteng 1724 South Africa |
X/20.2.6/84
|
BTF1332A |
10/2026 |
500’s |
30 January 2025 |
Class II Type B |
28.November .2025 |
Brief description of the problem (reason for recall)
This recall is initiated due to discolouration of tablets. Based on micro testing, an out of specification result was observed in the TYMC (Total Yeast and Mould Count) of the tablets.
Advise for health professionals and distributors:
We request that you refrain from selling any of the affected batch of Bemetrazole 400mg, Batch BTF1332A. Please return all remaining stock to your supplying warehouse or distributor with immediate effect. Ranbaxy Pharmaceuticals (Pty) Ltd will retrieve all stock and pass credit accordingly.
For further product information, please call Ranbaxy Pharmaceuticals (Pty) Ltd on 011 495 0100 or SAHPRA.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated. A rapid alert was also shared with PIC’s member countries.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.