FDA-Drug2018-02-14Class I
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51
AuroMedics Pharma LLC
Hazard
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Sold states
Product was distributed throughout United States.
Affected count
9,050 bags
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0337-2018Don't want to check this manually?
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