PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 6, 2017 Initiated: November 9, 2017 #D-0096-2018

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.

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
3,870 bottles
Distribution
Nationwide
Location
North Wales, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Teva Pharmaceuticals USA. Units affected: 3,870 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 6, 2017. Severity: Moderate. Recall number: D-0096-2018.