FDA-Drug2022-04-13Class II

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 .

Pfizer Inc.
Hazard

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

Sold states
Nationwide
Affected count
195 bottles
Manufactured in
235 East 42nd Street, New York, NY, United States
Products
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 .

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0761-2022

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