Drug product
Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
D-1449-2016
Product summary
- Event
- Event 74509
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14, 370 units
- Official record key
drug-enforcement:D-1449-2016
Official wording
Reason: Failed Tablet/Capsule Specifications
Code information: Lot #: 02D163, Exp. 9/2017
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications