FDA recall D-0705-2017

Product

Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel

Reason for recall

Microbial Contamination of Non-Sterile Products

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-04-24

Report date

2017-05-17

Termination date

2018-02-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0705-2017