Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Ba...
FDA Recall #D-0088-2023 — Class II — December 7, 2022
Product Description
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
Reason for Recall
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
30,612 bottles
Distribution
Product was distributed by major distribution chains nationwide.
Code Information
Lot #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated