FDA Drug recall D-0089-2023
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2022-12-28
On 2022-12-28 the FDA classified a Class II recall of Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc by Lupin Pharmaceuticals, citing CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0089-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-12-07 |
| Published | 2022-12-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Identifiers
| ndc | 68180-556-09 |
|---|---|
| ndc | 68180-557-09 |
| ndc | 68180-557-03 |
| ndc | 68180-558-09 |
| ndc | 68180-558-03 |
| ndc | 68180-554-09 |
| ndc | 68180-554-03 |
| ndc | 68180-559-03 |
| ndc | 68180-559-09 |
| code_info | Lot #: G102929, Exp 04/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Lupin Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0089-2023%22
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