D-0761-2022 Class II Terminated
FDA drug recall D-0761-2022 was initiated by Pfizer Inc. on Mar 21, 2022 and is designated Class II. Reason for recall: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. The recall status is terminated (terminated Aug 28, 2024). Affected quantity: 195 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 13, 2022
- Initiation Date
- Mar 21, 2022
- Termination Date
- Aug 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0761-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026