FDA Drug Class II — Moderate

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

Hazard

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

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Products

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
Brand
Lupin Pharmaceuticals Inc.
UPC
Lot #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024

Units Affected

30,612 bottles

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