Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distr...
FDA Recall #D-0761-2022 — Class II — March 21, 2022
Product Description
Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .
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
195 bottles
Distribution
Nationwide
Code Information
Lot FG5381; Exp. 08/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated