27 Aug Ciplasyl Plus 4 tablets
| Company name & Address: | Registration number | Batch number(s) | Expiry date | Pack size | First Distribution date | Re-call Classification | Recall date |
| Zydus Healthcare SA (Pty) Ltd
Southdowns Office Park, Building A, 2nd Floor 22 Karee Street Centurion 0157 |
44/7.1.3/0503 |
MA04847A
MB02129A MA04848A MA04900A MB02127A MB02128A |
MA04847A Exp.10/2028 MB02129A Exp.02/2029
MA04848A Exp.10/2028 MA04900A Exp.10/2028 MB02127A Exp. 02/2029 MB02128A Exp. 02/2029
|
30’s |
MA04847A – 12/02/2026 MB02129A – 06/05/2026
MA04848A – 19/01/2026 MA04900A – 12/02/2026 MB02127A – 06/05/2026 MB02128A – 17/06/2026
|
Class II Type B |
25 August 2026 |
Brief description of the problem (reason for recall)
This recall has been initiated following the observation of an out-of-specification (OOS) result for tablet hardness during ongoing stability studies.
Advice for health professionals and distributors:
Zydus Healthcare kindly request that you immediately cease the sale and distribution of the affected batch(es) of Ciplasyl Plus 4 tablets and return the products to your supplying warehouse or distributor with immediate effect for a full credit/replacement.
Should you require any further information regarding this recall, please contact Zydus Healthcare (Pty) Ltd on +27 12 748 6400.
We sincerely appreciate your cooperation and apologise for any inconvenience this recall may cause.
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.