Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufact...
FDA Recall #D-1382-2020 — Class II — July 7, 2020
Product Description
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
64,344 bottles
Distribution
Product was distributed throughout the United States.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated