Why it was recalled
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
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
Lot numbers, UPCs & expiration codes
Lot #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024
Where it was sold
Product was distributed by major distribution chains nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0088-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 7, 2022
- FDA report date
- Dec 28, 2022
- Quantity
- 30,612 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0088-2023, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 91279
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024
- Postal code
- 21202-6174
- Report date
- Dec 28, 2022
- Product type
- Drugs
- Recall number
- D-0088-2023
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 30,612 bottles
- Termination date
- Aug 1, 2024
- Reason for recall
- CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed by major distribution chains nationwide.
- Recall initiation date
- Dec 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2022