Drug product
Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
D-0874-2022
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 90064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8346 bottles
- Official record key
drug-enforcement:D-0874-2022
Official wording
Reason: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Code information: Lots: DX6031 Exp. MAR 31 2023; CK6260 Exp. MAY 31 2022
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations