| TGA Action ID |
RC-2024-RN-00043-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Metformin Sandoz 1000 mg Tablet 90s Blister
Batch Number: E920021
Expiry Date: Jan 2025
ARTG 292865
(METFORMIN SANDOZ metformin hydrochloride 1000 mg tablet blister pack) |
| ARTG Number |
292865 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
Sandoz Pty Ltd has informed the TGA Recalls Section of recovery of N-Nitrosodimethylamine (NDMA) impurity present in Batch Number E920021 of Metformin Sandoz 1000 mg film-coated tablets. |
| Instructions for Customers/Users |
Customers are to Inspect stock immediately and quarantine affected stock of Metformin batch E920021 on hand to prevent further use.
Pharmacies are to contact their wholesaler to arrange for the return of the stock and a suitable refund will be applied.
Wholesalers are to contact Sandoz to arrange for return of the stock and a suitable refund.
This action has been finalised on 17/6/2024. |
| Action Commencement Date |
17/01/2024 |
| Responsible Entity |
|
| Contact Information |
1800 726 369 - Sandoz Customer Service |