FDA recall D-0574-2018

Product

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

Reason for recall

Presence of Particulate Matter; contains visible particulate matter identified as mold.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-01-12

Report date

2018-03-07

Termination date

2020-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2018