FDA-Drug2018-03-07Class I
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46
AuroMedics Pharma LLC
Hazard
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Sold states
Nationwide
Affected count
6,072 bags
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2018Don't want to check this manually?
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