Drug product
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.
D-0208-2018
Product summary
- Event
- Event 78753
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,969 bottles
- Official record key
drug-enforcement:D-0208-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Code information: Lot # 30229439A, Exp 12/17
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification