FDA-Drug2016-09-14Class II

Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)

Teva North America
Hazard

CGMP Deviations

Sold states
Nationwide and Puerto Rico
Affected count
92,480 containers
Manufactured in
425 Privet Rd, Horsham, PA, United States
Products
Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1495-2016

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