FDA Drug Class II — Moderate

Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09

Hazard

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

Products

Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
Brand
Lupin Pharmaceuticals Inc.
UPC
Lot #: G102929, Exp 04/2023

Units Affected

23,736