12 Oct Riqviva 100 and 400 (Bevacizumab)
| 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 |
56/26/0604 56/26/0605 |
N250621B N250634A |
07/2028 08/2028
|
Vial 5ml & 20ml |
30 November 2025 23 January 2026 |
Class II Type B |
07 October 2026 |
Brief description of the problem (reason for recall)
Dr. Reddy’s Laboratories (Pty) Ltd in collaboration with the South African Health Products Regulatory Authority (SAHPRA), is recalling the below-mentioned batches of Riqviva concentrate for solution for infusion with immediate effect as a precautionary measure.
This recall was initiated due to an Out of Trend (OOT) total aggregates testing result during routine long-term stability testing. The product batches currently are still within the specification limit but, due to future projections an Out of Specification (OOS) testing result may be recorded. These batches will be voluntary recalled from the market as a precautionary measure.
Advice for health professionals and distributors:
A medical risk assessment has been completed however no life-threatening situation is expected, the possibility of future remote chances of unspecified adverse effects cannot be completely ruled out. As a precautionary measure a product recall is initiated.
Please immediately quarantine any units of the above-mentioned batches 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.