February 16, 2018
The presence of particulate matter identified as glass and mold has prompted AuroMedics Pharma to voluntarily recall 2 lots of injection drugs. According to the February 14, 2018, US Food and Drug Administration (FDA) Enforcement Report, both recalls have been designated Class I, indicating that use of the affected medications could cause serious health problems or death.
The recall includes linezolid injection 600 mg/300 mL (2 mg/mL), 300-mL single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap (NDC 55150-242-51). The recalled infusion bags were from lot CLZ160007, which has an August 2018 expiration date. The lot contained 9050 infusion bags.
Also recalled is pantoprazole sodium for injection, 40-mg single-dose vials (NDC 55150-202-00) from lot CPO170035. No expiration date was provided for the lot, but the FDA reported it included 66,100 vials.
Both recalled lots were distributed throughout the United States.
After discovering a piece of glass in a pantoprazole sodium vial, AuroMedics Pharma initiated the recall December 4, 2017. The firm initiated the linezolid injection recall December 20, 2017, when white particulate matter, identified as mold, was found in an infusion bag.
Linezolid injection is an antibiotic medication used to treat certain bacterial infections. Pantoprazole sodium for injection, a proton pump inhibitor, is used to treat conditions involving excess stomach acid, such as erosive esophagitis.
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