FDA-Drug2022-12-28Class II

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

Lupin Pharmaceuticals Inc.
Hazard

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

Sold states
Product was distributed by major distribution chains nationwide.
Affected count
30,612 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0088-2023

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