Drug product
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93
D-1006-2019
Product summary
- Event
- Event 82367
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7,081 bottles
- Official record key
drug-enforcement:D-1006-2019
Official wording
Reason: Subpotent Drug.
Code information: Lot #: 25Q002, Exp. 11/2019
Distribution pattern: Nationwide in the United States.
Derived failure modes
-
Potency or specification failure
Subpotent