Drug product
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454
D-0381-2019
Product summary
- Event
- Event 81840
- Status
- Terminated
- Classification
- Class II
- Quantity
- 181,456 bottles
- Official record key
drug-enforcement:D-0381-2019
Official wording
Reason: Failed dissolution specifications
Code information: Lot #: a) 49O005, 49O006, 49O007, 49O010, Exp 02/2019; b) 49O005, 49O009, 49O010, Exp 02/2019
Distribution pattern: U.S.A. nationwide
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications