Teva Pharmaceuticals USA recalls Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceutica…

Recall date

March 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0859-2016

FDA classification

Class I

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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