Drug product
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.
D-0756-2022
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 89864
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1364 bottles
- Official record key
drug-enforcement:D-0756-2022
Official wording
Reason: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Code information: Lot EA6665, Exp Date 04/2022, Lot CN0640, Exp Date 04/2022
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-hydrochlorothiazide impurity
-
Manufacturing or process control
CGMP Deviations