Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, D...
FDA Recall #D-0755-2022 — Class II — March 21, 2022
Product Description
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23
Reason for Recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Recalling Firm
Pfizer Inc. — New York, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
160 bottles
Distribution
Nationwide
Code Information
Lot EA6686; Exp. 04/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated