27 Apr ACCORD-VINCRISTINE 1 mg/ml, 2ml (Vincristine Sulfate)
| Company name & Address: | Registration number | Batch number(s) | Expiry date | Pack size | First distributed | Re-call Classification | Recall date |
| Accord Healthcare (Pty) Ltd
Building 31, Woodlands Office Park, 20 Woodlands Drive, Woodmead, 2191, South Africa |
41/26/1002 |
M2309730 |
June.2025 |
1 glass vial in monocarton |
31.October.2023 |
Class II Type B |
25.June.2025 |
Brief description of the problem (reason for recall)
This recall is initiated because out of specification result observed for Assay of Propyl Parahydroxybenzoate (excipient) during routine stability testing of Vincristine Sulfate Injection.
Advice for health professionals and distributors
We request that you refrain from selling the affected batch of Accord Vincristine 1 mg/ml, 2 ml and return them to your supplying warehouse or distributor with immediate effect. Accord Healthcare (Pty) Ltd will replace affected stock.
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
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.