Recalls / Class II
Class IID-0096-2018
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
- Affected lot / code info
- Lot # 39C192, exp 06/2019
Why it was recalled
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 3,870 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-11-09
- FDA classified
- 2017-11-27
- Posted by FDA
- 2017-12-06
- Terminated
- 2018-07-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0096-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.