AuroMedics Pharma issued a voluntary nationwide recall for one lot of its flexible bags containing the antibiotic linezolid for injection. The company issued the recall after the products were found to contain white particulate matter identified as mold, according to a recall announcement published by the Food and Drug Administration on Dec. 22.
Here are five things to know.
1. The product was distributed to wholesalers and hospitals around the country from May 15 through Aug. 14.
2. AuroMedics has notified customers of the recall via recall letters.
3. Use of the product should be immediately discontinued and could potentially result in fatal infections in many patients.
4. AuroMedics has not received any reports of adverse events attributable to the recalled antibiotic.
5. Linezolid injection is used to treat multiple infections caused by gram-negative bacteria, including vancomycin-resistant Enterococcus faecium, community-acquired pneumonia and diabetic foot infections.
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