RA Drug Methotrexate Is Recalled

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RA Drug Methotrexate Is Recalled

Glass Flakes in Injectable Rheumatoid Arthritis Drug Spur Recall

By J. DeNoon

WebMD Health News

Reviewed by J. , MD

Oct. 28, 2010 -- Glass flakes have led to the recall of Sandoz and Parenta brand

injectable methotrexate, a drug used to treat rheumatoid arthritis, cancer, and

psoriasis.

The glass flakes " are the result of delamination of the glass used to

manufacture the vials " of two dosages of the drug, the FDA says in a news

release.

" There is the potential to develop adverse reactions in areas where the

particles lodge, " the FDA says. " Injection of drug from the affected lots could

lead to serious adverse events, resulting in disability and death. Additionally,

neurologic damage could result from intrathecal [spinal] administration. "

There have been no reports of adverse events to date.

Customers and patients should immediately discontinue use of this product and

patients should contact their doctor or health care provider if they experience

any problem that might be related to the use of this product.

Adverse events related to the use of Sandoz methotrexate product should be

reported to Sandoz at 800-525-8747 800-525-8747 or to the

FDA's MedWatch Adverse Event Reporting Program.

The recall applies to all 50 mg/2 mL and 250 mg/10 mL vials of the drugs:

Product : Methotrexate Injection, USP, 50 mg/2 mL

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, 250 mg/10 mL

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