FDA recall D-1497-2016

Teva North America · Class II · drug

Product

Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)

Reason for recall

CGMP Deviations

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2016-06-17
Report date: 2016-09-14
Termination date: 2017-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1497-2016