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TGA Action ID	RC-2024-RN-00804-1
Type of Product	Medicine
Product Name/Description	Metformin 500mg Tablet 100s Blister Batch: E930006, E930024, E930027, E930028, E930037, E930035, E930036, E930076, E930077, E930078, E930093, E930094, E930100, E930114, E930115 Expiry: Dec-2025, Jan-2026, Jan-2026, Jan-2026, Feb-2026, Feb-2026, Feb-2026, Apr-2026, Apr-2026, Apr-2026, May-2026, May-2026, May-2026, June-2026, June-2026 ARTG 125661
ARTG Number	125661
Action Type	Recall
Action Level	Retail
Hazard Classification	Class II
Reason for the Action	Sandoz Pty Ltd has informed the TGA of recovery of NDMA impurity present in four (4) batches of Metformin 500mg and an additional eleven (11) batches at risk of becoming out of specification within their shelf life.
Instructions for Customers/Users	Customers are to inspect stock immediately and quarantine affected stock of Metformin batches on hand to prevent further use. Pharmacies: Contact wholesaler to arrange for the return of the stock and a suitable refund will be applied. Wholesalers: Contact Sandoz to arrange for return of the stock and a suitable refund will be applied. This action has been finalised on 11/9/2025.
Action Commencement Date	8/11/2024
Responsible Entity	Sandoz Pty Ltd
Contact Information	1800 726 369 – Sandoz Customer Service