Why it was recalled
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Product description
Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
Lot numbers, UPCs & expiration codes
Lots: DX8682 Exp. MAR 31 2023; DG1188 Exp. MAR 31 2022
Where it was sold
Nationwide and Puerto Rico
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-0873-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 22, 2022
- FDA report date
- May 25, 2022
- Quantity
- 10,304 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0873-2022, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 90064
- Address
- 235 East 42nd Street
- Code information
- Lots: DX8682 Exp. MAR 31 2023; DG1188 Exp. MAR 31 2022
- Postal code
- 10017-5703
- Report date
- May 25, 2022
- Product type
- Drugs
- Recall number
- D-0873-2022
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 10,304 bottles
- Termination date
- Oct 5, 2023
- Reason for recall
- CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 22, 2022
- Initial firm notification
- Press Release
- Center classification date
- May 16, 2022