D-0088-2023 Class II Terminated
FDA drug recall D-0088-2023 was initiated by Lupin Pharmaceuticals Inc. on Dec 7, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. The recall status is terminated (terminated Aug 1, 2024). Affected quantity: 30,612 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 28, 2022
- Initiation Date
- Dec 7, 2022
- Termination Date
- Aug 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,612 bottles
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
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 #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0088-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026