Metformin Hydrochloride Extended-release Tablets USP recall: Nitrosamine Impurity
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured…
Why was Metformin Hydrochloride Extended-release Tablets USP recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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?
Batch# G808201 Aug-20 G808202 Aug-20 G808200 Aug-20 G900935 Dec-20 G901311 Dec-20 G900957 Dec-20 G900958 Dec-20 G901006 Dec-20 G904803 May-21 G904804 May-21 G906551 Jul-21 G906552 Jul-21 G907375 Aug-21 G908605 Oct-21 G908604 Oct-21 G002108 Jan-22 G002109 Jan-22 G002559 Feb-22 G002560 Feb-22
- Product
- Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 64,344 bottles
- Distribution
- Product was distributed throughout the United States.
- Recall date
- July 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)