Recalls / Class II
Class IID-0089-2023
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
- Brand name
- Quinapril
- Generic name
- Quinapril
- Active ingredient
- Quinapril Hydrochloride
- Route
- Oral
- NDCs
- 68180-554, 68180-556, 68180-557, 68180-558, 68180-559
- FDA application
- ANDA077690
- Affected lot / code info
- Lot #: G102929, Exp 04/2023
Why it was recalled
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 23,736
- Distribution pattern
- Product was distributed by major distribution chains nationwide.
Timeline
- Recall initiated
- 2022-12-07
- FDA classified
- 2022-12-23
- Posted by FDA
- 2022-12-28
- Terminated
- 2024-08-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0089-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.