Drug product
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
D-0088-2023
Product summary
- Event
- Event 91279
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,612 bottles
- Official record key
drug-enforcement:D-0088-2023
Official wording
Reason: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Code information: Lot #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024
Distribution pattern: Product was distributed by major distribution chains nationwide.
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso-quinapril impurity
-
Manufacturing or process control
CGMP Deviations