FDA recall D-0868-2016

Product

Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454

Reason for recall

Lack of Assurance of Sterility: Due to potential for leaking bags.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-04-27

Report date

2016-06-01

Termination date

2018-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0868-2016