D-0758-2022 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
2442 bottles

Product Description

quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9

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 FE3714; Exp. 02/2023