Metformin Hydrochloride Extended-Release Tablets USP recall: Nitrosamine Impurity
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 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 # G807093 Jul-20 G807147 Jul-20 G807208 Jul-20 G807479 Jul-20 G807480 Jul-20 G807830 Jul-20 G807092 Jul-20 G809471 Jul-20 G808155 Aug-20 G808074 Aug-20 G808115 Aug-20 G900231 Nov-20 G900232 Nov-20 G903277 Mar-21 G903278 Mar-21 G903279 Mar-21 G903280 Mar-21 G903281 Mar-21 G903818 Apr-21 G904048 Apr-21 G904164 Apr-21 G906548 Jul-21 G907239 Aug-21 G907255 Aug-21 G907256 Aug-21 G907263 Aug-21 G001802 Jan-22 G001804 Jan-22 G001803 Jan-22 G001805 Jan-22 G001806 Jan-22 G001807 Jan-22 G001808 Jan-22 G808154 Aug-20 G900227 Nov-20 G900228 Nov-20 G900229 Nov-20 G900230 Nov-20 G906549 Jul-21 G906550 Jul-21 G906547 Jul-21 G907279 Aug-21 G907364 Aug-21 G001809 Jan-22 G001801 Jan-22 G002563 Feb-22 G002564 Feb-22
- Product
- Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 95,886 bottles
- Distribution
- Product was distributed throughout the United States.
- Recall date
- July 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)