FDA recall D-0089-2023

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 for recall

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

Distribution

Product was distributed by major distribution chains nationwide.

Key facts

Status

Terminated

Initiation date

2022-12-07

Report date

2022-12-28

Termination date

2024-08-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0089-2023