Rheumatoid Arthritis (RA) Drug Methotrexate has been recalled from market as some lots were found to be faulty. Glass Flakes were found in Injectable Rheumatoid Arthritis Drug which spurred the recall. Following are FDA statements and the lot numbers which have been recalled. I would like to thank Cynthia White on precautioning people early on my facebook page.

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