Metformin Hydrochloride Extended-Release Tablets recall: Nitrosamine Impurity
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9…
Why was Metformin Hydrochloride Extended-Release Tablets recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots remaining within expiry
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9…
- Recalling firm
- Apotex Inc.
- Quantity
- 305,963 bottles
- Distribution
- Nationwide.
- Recall date
- June 24, 2020
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)