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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.

July 17, 2011 at 9:00 am
(1) Psoriasis Types says:

I never had any side effect, I never vomited either when I took the pills. I was switched to injectable Methotrexate on Nov.30 of last year, so I give myself a weekly injection. I already consult with my doctor referring The FDA new safety alert, and he said it’s not nothing I personally should worried about. I just wanted to report that here as regular reader of this category.

Bless You

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