Recall: D-0574-2018

Class I - Dangerous

Class IClassification

2018-01-12Initiated

TerminatedStatus

AuroMedics Pharma LLCFirm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.