FDA announces recall of contaminated antibiotic
A pharmaceutical company has issued a recall of an injectable antibiotic that contains mold.
The problem was discovered when a product complaint led to the discovery of a white, particulate matter floating in a flexible bag containing the drug.
AuroMedics Pharma LLC is recalling one lot of Linezolid Injection 600/300mL flexible bags that was distributed from May 15 through Aug. 14.
The use of a non-sterile injectable product can result in fatal infections in a broad array of patients, the FDA said in its recall notice. So far, AuroMedics has not received any reports of adverse events or identifiable safety concerns attributed to the recall, the release stated.
The oxazolidinone-class antibacterial is used in adults and children for the treatment of bacterial infections including several types of pneumonia, foot infections related to diabetes and other causes; skin and skin structure lesions and other infections that are resistant to other antibiotics.
Consumers with questions about the recall can contact AuroMedics Customer Service at 1-866-850-2876.