FDA Drug Recalls

Recalls / Class II

Class IID-0873-2022

Product

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

Affected lot / code info
Lots: DX8682 Exp. MAR 31 2023; DG1188 Exp. MAR 31 2022

Why it was recalled

CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Recalling firm

Firm
Pfizer Inc.
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
235 East 42nd Street, N/A, New York, New York 10017-5703

Distribution

Quantity
10,304 bottles
Distribution pattern
Nationwide and Puerto Rico

Timeline

Recall initiated
2022-04-22
FDA classified
2022-05-16
Posted by FDA
2022-05-25
Terminated
2023-10-05
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0873-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls