FDA recall D-0859-2016

Product

Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03

Reason for recall

Presence of Particulate Matter: particulate matter identified as glass in one vial.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-03-09

Report date

2016-06-01

Termination date

2017-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0859-2016