Levofloxacin in 5% Dextrose Injection recalled over mold contamination

Recall date

January 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactur…

Recall number

D-0574-2018

FDA classification

Class I

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

Nationwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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