D-0096-2018 Class II Terminated
FDA drug recall D-0096-2018 was initiated by Teva Pharmaceuticals USA on November 9, 2017 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications; potential presence of broken tablets. The recall status is terminated (terminated July 3, 2018). Affected quantity: 3,870 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 6, 2017
- Initiation Date
- November 9, 2017
- Termination Date
- July 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,870 bottles
Product Description
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
Reason for Recall
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Distribution Pattern
Nationwide
Code Information
Lot # 39C192, exp 06/2019