Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only...
FDA Recall #D-0756-2022 — Class II — March 21, 2022
Product Description
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.
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
1364 bottles
Distribution
Nationwide
Code Information
Lot EA6665, Exp Date 04/2022, Lot CN0640, Exp Date 04/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated