Status
Terminated
Drug Enforcement D-0088-2023
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Classification
Class II
Report Date
December 28, 2022
Termination Date
August 1, 2024
Product Information
- Product description
- 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
- Product quantity
- 30,612 bottles
- Reason for recall
- CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed by major distribution chains nationwide.
Location & Firm
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Address
-
Harborplace Tower, 111 S Calvert St Fl 21st
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0088-2023
- Event ID
- 91279
- Recall initiation date
- December 7, 2022
- Center classification date
- December 23, 2022
- Code info
- Lot #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024
- More code info
- —