Recall Enforment Report D-0088-2023

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 12-07-2022 for the product Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09 The product was recalled due to cgmp deviations: detection of n-nitroso-quinapril impurity above the acceptable daily intake limit.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0088-202312-07-202212-28-2022Class II30,612 bottlesQuinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.Ongoing
D-0089-202312-07-202212-28-2022Class II23,736Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68180-554Quinapril QuinaprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-556Quinapril QuinaprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-557Quinapril QuinaprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-558Quinapril QuinaprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug