FDA Recall Accupril
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Accupril with NDC 0071-0530 was initiated on 04-22-2022 as a Class II recall due to cgmp deviations: contains n-nitrosoquinapril above the acceptable limits. The latest recall number for this product is D-0872-2022 and the recall is currently terminated as of 10-05-2023 .
Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
---|---|---|---|---|---|---|
D-0872-2022 | 04-22-2022 | 05-25-2022 | Class II | 2079 bottles | Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017 | Terminated |
D-0873-2022 | 04-22-2022 | 05-25-2022 | Class II | 10,304 bottles | 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 | Terminated |
D-0874-2022 | 04-22-2022 | 05-25-2022 | Class II | 8346 bottles | 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 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.