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Sandoz, Inc. Recalls Two Lots of Injectable Methotrexate



5/23/2013 7:43:16 AM

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Sandoz is conducting a voluntary nationwide recall at the US hospital/user level of 2 lots of its injectable methotrexate sodium, USP, 25 mg/mL, 40 mL vials, as a result of the discovery of particulate matter during routine quality examination of vials included among the manufacturer’s retention samples. The lot numbers and expiration dates of the 2 recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). They were distributed nationally across the United States, as well as to Poland. According to an FDA Safety Announcement, parenteral injection of drug from the affected lots can lead to microembolization in areas where the particles lodge. Clinical symptoms are not to be expected from these microemboli and Sandoz is unaware of any reports of related adverse events.

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