Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufact...
FDA Recall #D-1385-2020 — Class II — July 7, 2020
Product Description
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07
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
273,060 bottles
Distribution
Product was distributed throughout the United States.
Code Information
Batch # G807619 Jul-20 G807620 Jul-20 G807733 Jul-20 G807734 Jul-20 G807735 Jul-20 G807445 Jul-20 G807617 Jul-20 G807618 Jul-20 G808042 Jul-20 G808043 Jul-20 G807349 Jul-20 G807350 Jul-20 G807444 Jul-20 G807507 Jul-20 G807508 Jul-20 G807314 Jul-20 G807316 Jul-20 G807325 Jul-20 G807348 Jul-20 G807616 Jul-20 G807312 Jul-20 G807313 Jul-20 G807315 Jul-20 G808374 Aug-20 G808427 Aug-20 G808373 Aug-20 G808426 Aug-20 G900057 Oct-20 G900058 Oct-20 G900059 Oct-20 G900060 Oct-20 G900061 Oct-20 G900062 Oct-20 G900106 Oct-20 G900140 Oct-20 G900141 Oct-20 G900152 Oct-20 G809596 Oct-20 G809598 Oct-20 G810182 Oct-20 G810183 Oct-20 G810184 Oct-20 G810185 Oct-20 G810186 Oct-20 G810187 Oct-20 G810188 Oct-20 G810189 Oct-20 G809554 Oct-20 G809556 Oct-20 G809557 Oct-20 G809558 Oct-20 G809559 Oct-20 G809548 Oct-20 G809549 Oct-20 G809550 Oct-20 G809551 Oct-20 G809552 Oct-20 G809553 Oct-20 G809555 Oct-20 G901004 Dec-20 G901005 Dec-20 G901053 Dec-20 G901002 Dec-20 G901003 Dec-20 G903182 Mar-21 G903183 Mar-21 G903236 Mar-21 G903237 Mar-21 G903238 Mar-21 G903155 Mar-21 G903156 Mar-21 G903157 Mar-21 G903158 Mar-21 G903159 Mar-21 G903178 Mar-21 G903179 Mar-21 G903180 Mar-21 G903181 Mar-21 G903239 Mar-21 G001837 Jan-22 G001860 Jan-22 G001861 Jan-22 G001905 Jan-22 G001933 Jan-22 G001934 Jan-22 G001763 Jan-22 G001764 Jan-22 G001765 Jan-22 G001766 Jan-22 G001767 Jan-22 G001795 Jan-22 G001836 Jan-22
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated