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

Recall Number: D-0859-2016

Firm: Teva Pharmaceuticals USA

Classification: Class I

Status: Terminated

Report Date: 20160601

Initiation Date: 20160309

Termination Date: 20170207

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

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