Linezolid Injection recalled over sterility concerns

Recall date

April 27, 2016

Source

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

Official notice title

Teva North America recalls Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Con…

Recall number

D-0868-2016

FDA classification

Class II

Brand / firm

Teva North America

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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