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Safety Alert: Methotrexate Recall

The FDA has issued a safety alert for some vials of methotrexate, which may contain small flakes of glass. Sandoz is recalling the following products:

Product : Methotrexate Injection, USP, 50mg/2mL
NDC Number : 66758-040-02 (10 vial pack) and 66758-040-01 (Individual vial)

Lot Number
Label Type
Exp Date
92395606 Parenta 12/2010
92760803 Parenta 2/2011
92965104 Parenta 3/2011
92965106 Parenta 3/2011
92965904 Parenta 4/2011
93255704 Parenta 6/2011
93502204 Parenta 7/2011
93635404 Parenta 8/2011
93681704 Parenta 8/2011
93794904 Sandoz 9/2011
95198604 Sandoz 10/2011
95357804 Sandoz 12/2011
95537704 Sandoz 1/2012
95987004 Sandoz 3/2012



Product : Methotrexate Injection, USP, 250mg/10mL
NDC Number : 66758-040-08 (10 vial pack) and 66758-040-07 (Individual vial)

Lot Number
Label Type
Exp Date
92395703 Parenta 12/2010
92760903 Parenta 2/2011
92965203 Parenta 3/2011
92966003 Parenta 4/2011
93255803 Parenta 6/2011
93502303 Parenta 7/2011
93635503 Parenta 8/2011
93795003 Sandoz 9/2011
95198703 Sandoz 10/2011
95357903 Sandoz 12/2011

If you have one of the affected vials, call the dedicated Methotrexate Recall Hotline at 1-888-896-4565 (staffed around the clock) or email Sandoz.methotrexaterecall@gencopharma.com. If you have already used some of the methotrexate and have experienced any side effects that you think might be related to the recall, contact your doctor right away.

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