FDA Recalls NDC 0071-0535 Accupril
Quinapril Hydrochloride Tablet, Film Coated Oral

FDA Recalls Enforcement Reports

The last Recall Enforcement Report for Accupril with NDC 0071-0535 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 ongoing .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0872-202204-22-202205-25-2022Class II2079 bottlesAccupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017Ongoing
D-0874-202204-22-202205-25-2022Class II8346 bottlesAccupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017Ongoing
D-0873-202204-22-202205-25-2022Class II10,304 bottlesAccupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017Ongoing

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.