FDA recall D-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

Reason for recall

Failed Tablet/Capsule Specifications; potential presence of broken tablets.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-11-09

Report date

2017-12-06

Termination date

2018-07-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0096-2018