07 May Apixaban 2,5 DRL (Apixaban)
| Company name & Address: | registration number | Batch number(s) | Expiry date | Pack size | First release date | Re-call Classification | Recall date |
| Dr Reddy’s Laboratories (Pty) Ltd
Block C, Woodmead North Office Park, 54 Maxwell Drive, Woodmead, Sandton |
56/8.2/0106 |
T2504569 |
August 2027 |
60’s |
21 January 2026 |
Class II Type B |
04 May 2026 |
Brief description of the problem (reason for recall)
This recall is initiated due to Out of Specification (OOS) dissolution result during routine long term stability testing.
Advice for health professionals and distributors:
Dr Reddy’s Laboratories (Pty) Ltd advises that you 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.
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.