23 Sep Diamet XR 1000 (Metformin Hydrochloride)
| Company name & Address: | Registration number | Batch number(s) | Expiry date | Pack size | First Distribution date | Re-call Classification | Recall date |
| 100 Northern Parkway Rd
Crownwood Office, Block D Groundfloor Ormonde 20291 |
57/21.2/0123 |
5251059 |
September 2028
|
60’s |
April 2026 |
Class III Type C |
17 September 2026 |
Brief description of the problem (reason for recall)
This recall is initiated because one side panel of the carton (secondary packaging) incorrectly states the active ingredient strength as “Metformin Hydrochloride 100 mg” instead of “Metformin Hydrochloride 1000 mg”. The error is limited to that single panel; the remaining carton panels, the blister foil, the professional information and the patient information leaflet all state the correct strength, and the Certificate of Analysis confirms that the batch complies with the approved specification.
Advice for health professionals and distributors:
We request that you refrain from selling any of the affected batch of Diamet XR 1000, quarantine the stock in your possession and return it to your supplying warehouse or distributor for a full credit with immediate effect.
For further product information, please call Innovata Pharmaceuticals (Pty) Ltd on +27 (0) 86 999 0912 or email [regulatory@innovata.co.za].
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.