RA Drug Methotrexate Is Recalled

Glass Flakes in Injectable Rheumatoid Arthritis Drug Spur Recall

By Daniel J. DeNoon
WebMD Health News

Reviewed by Laura J. Martin, 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 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

SOURCE: News release, FDA.

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