FDA recall D-0296-2015

Fresenius Kabi USA, LLC · Class II · drug

Product

ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02

Reason for recall

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Distribution

U.S. Nationwide Including Puerto Rico

Key facts

Status: Terminated
Initiation date: 2012-09-27
Report date: 2014-12-17
Termination date: 2014-12-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0296-2015