D-0089-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 28, 2022
- Initiation Date
- December 7, 2022
- Termination Date
- August 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,736
Product Description
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 Pattern
Product was distributed by major distribution chains nationwide.
Code Information
Lot #: G102929, Exp 04/2023