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  3. Recall Enforcement Event ID: 85998

Recall Enforment Report D-1382-2020

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 07-07-2020 for the product 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 The product was recalled due to cgmp deviations: fda analysis detected n-nitrosodimethylamine (ndma) impurity above the acceptable intake level. The product was distributed in Product Was Distributed Throughout The United States. and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1382-202007-07-202007-22-2020Class II64,344 bottlesMetformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelTerminated
D-1383-202007-07-202007-22-2020Class II95,886 bottlesMetformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelTerminated
D-1385-202007-07-202007-22-2020Class II273,060 bottlesMetformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelTerminated
D-1384-202007-07-202007-22-2020Class II59,568 bottlesMetformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelTerminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68180-336Metformin Hydrochloride Metformin HydrochlorideTablet, Extended ReleaseOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-337Metformin Hydrochloride Metformin HydrochlorideTablet, Extended ReleaseOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-338Metformin Hydrochloride Metformin HydrochlorideTablet, Extended ReleaseOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-339Metformin Hydrochloride Metformin HydrochlorideTablet, Extended ReleaseOralLupin Pharmaceuticals, Inc.Human Prescription Drug