FDA-Drug2016-06-01Class II
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
Teva North America
Hazard
Lack of Assurance of Sterility: Due to potential for leaking bags.
Sold states
Nationwide
Affected count
546 bags
Manufactured in
425 Privet Rd, N/A, Horsham, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0868-2016Don't want to check this manually?
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