D-0757-2022 Class II Terminated

Recalled by Pfizer Inc. — New York, NY

Recall Details

Product Type
Drugs
Report Date
April 13, 2022
Initiation Date
March 21, 2022
Termination Date
August 28, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
265 bottles

Product Description

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.

Reason for Recall

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Distribution Pattern

Nationwide

Code Information

Lot ET6974; Exp. 02/2023