Recall: D-0089-2023

Class II - Potentially Harmful

Class IIClassification

2022-12-07Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

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

Reason

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

Distribution

Product was distributed by major distribution chains nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.