Drug product
quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1
D-0760-2022
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 89864
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1104 bottles
- Official record key
drug-enforcement:D-0760-2022
Official wording
Reason: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Code information: Lot DP3414; Exp 02/2023
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-hydrochlorothiazide impurity
-
Manufacturing or process control
CGMP Deviations