29 Sep Eribulin DRL (Eribulin Mesylate)
| Company name & Address: | Registration number | Batch number | Expiry date | Pack size | First Distribution date | Re-call Classification | Recall date |
| Dr Reddys Laboratories (Pty) Ltd Block C, Woodmead North Office Park, 54 Maxwell Drive, Woodmead Sandton, Gauteng South Africa | 57/26/0539 | H260193 | November 2027 | 2ml Vial | 26 May 26 | Class II Type C | 22 September 2026 |
Brief description of the problem (reason for recall)
This recall is initiated due to extrapolated potential Out of Specification (OOS) assay result during routine long term stability testing. During Stability testing of different Eribulin batches, assay Out of Specification (OOS) results were recorded. Although the specific batch received in South Africa was not placed on stability, batch (H260193) will be recalled from the market as a precautionary measure.
Advice for health professionals and distributors:
Please immediately quarantine any units of the above-mentioned batch that you have in your possession and return via your normal distribution channel for full credit.
We apologize for any inconvenience and appreciate your assistance in this matter. Should you have any queries, please contact:
Dr Reddy’s Laboratories (Pty) Ltd
Tel: 011 3242100
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.