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FDAFDA · Food and drugs·Recall number D-0859-2016

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

Published June 1, 2016 · Recall initiated: March 9, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Teva Pharmaceuticals USA
Distributor
Nationwide and Puerto Rico
Lot
Lot #: 4750915, Exp 9/2017
Risk classification
Class I
Area (FDA)
drug
Country
United States

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