01 Jun Ranceph Suspension 125 Mg/5 ML (Cephalexin Monohydrate)
| Company name & Address: | registration number | Batch number(s) | Expiry date | Pack size | First release date | Re-call Classification | Recall date |
| Ranbaxy Pharmaceuticals (Pty) Ltd
14 Lautre Road, Stormill Extension 1 Roodepoort Johannesburg 1724 |
32/20.1.1/0214
|
DFG4606A |
30 June 2027 |
100ml |
06 November 2025 |
Class II Type B |
20 May 2026 |
Brief description of the problem (reason for recall)
The recall is initiated because of an Out of Specification (OOS) result observed in the Related Substance test, for an Unidentified impurity, at the 6-month stability time point (25◦ C/60% RH).
Advice for health professionals and distributors:
Ranbaxy requests that you refrain from selling the affected batch of RANCEPH SUSPENSION 125 mg/5 ml, Batch DFG4606A. Please return all remaining stock to your supplying warehouse or distributor with immediate effect. Ranbaxy Pharmaceuticals (Pty) Ltd will collect all your stock which will be credited.
Kindly retain this letter in a prominent position for one month, in case there is stock in transit.
For further product information, please call Ranbaxy Pharmaceuticals (Pty) Ltd on 011 495 0100.e-mail: QA.SA@drreddys.com
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
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