Drug product
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
D-0096-2018
Product summary
- Event
- Event 78552
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,870 bottles
- Official record key
drug-enforcement:D-0096-2018
Official wording
Reason: Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Code information: Lot # 39C192, exp 06/2019
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications; potential presence of broken tablets.