D-0874-2022 Class II Terminated

Recalled by Pfizer Inc. — New York, NY

FDA drug recall D-0874-2022 was initiated by Pfizer Inc. on Apr 22, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. The recall status is terminated (terminated Oct 5, 2023). Affected quantity: 8346 bottles.

Recall Details

Product Type
Drugs
Report Date
May 25, 2022
Initiation Date
Apr 22, 2022
Termination Date
Oct 5, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8346 bottles

Product Description

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 Pattern

Nationwide and Puerto Rico

Code Information

Lots: DX6031 Exp. MAR 31 2023; CK6260 Exp. MAY 31 2022

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0874-2022
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.