FDA recall D-0874-2022

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

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-0874-2022