D-0761-2022 Class II Terminated
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
- 195 bottles
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.
Distribution Pattern
Nationwide
Code Information
Lot FG5381; Exp. 08/2024