Class I — High risk. Reasonable probability of serious harm or death.
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
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, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Reason CGMP Deviations
Reason Lack of Assurance of Sterility: Due to potential for leaking bags.
Reason Lack of sterility assurance.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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