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The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.
AuroMedics Pharma has voluntarily recalled one lot of linezolid injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007, with the expiration date of August 2018, to the hospital level due to mold contamination, FDA announced on Dec. 22, 2017.
The batch being recalled was distributed May 15–Aug. 14, 2017. The product was found to contain white particulate matter that has been identified as mold, which was discovered as a result of a product complaint in which the contents of one flexible bag from one batch, CLZ160007, 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 has not received reports of any adverse events or identifiable safety concerns attributed to this recall, according to FDA.
Linezolid injection is an oxazolidinone-class antibacterial used to treat infections caused by susceptible Gram-positive bacteria, including nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin-structure infections, uncomplicated skin and skin-structure infections, and vancomycin-resistant Enterococcus faecium infections. The product is supplied as a ready-to-use sterile, clear colorless to slightly yellow color isotonic solution for intravenous infusion.
AuroMedics Pharma is notifying its distributors and customers by recall letters and is arranging for return/replacement of all recalled product.