AuroMedics Pharma LLC issues voluntary nationwide recall of Levofloxacin in 5% Dextrose 250mg/50mL.
AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a single-use flexible container NDC 55150-243-46, Lot CLF160003, expiry date May 2018, to the hospital level.
The product has been found to contain visible particulate matter tentatively identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag was found to contain white particulate matter.
Use of a non-sterile injectable product could result in fatal infections in a broad array of patients. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall.
Levofloxacin injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the specified conditions.