FDA recall D-0872-2022

Pfizer Inc. · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status
Terminated
Initiation date
2022-04-22
Report date
2022-05-25
Termination date
2023-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0872-2022