FDA recall D-928-2013

Teva Pharmaceuticals USA, Inc. · Class II · drug

Product

CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11

Reason for recall

Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-08-13
Report date
2013-09-11
Termination date
2014-08-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-928-2013