Sandoz and Parenta Brands of Methotrexate Recalled Due to Glass Particulates

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Certain brands of injectable methotrexate, a drug used to treat conditions such as rheumatoid arthritis, cancer and psoriasis, have been recalled due to the potential that they contain glass flakes as a result “of the delamination of the class used to manufacture the vials.”

Sandoz and Parenta brands of methotrexate (lots and expiration dates listed below) are being recalled as a precaution after a limited number of vials in four lots were found to contain glass flakes. No adverse events have been reported, but “there is the potential to develop adverse reactions in areas where the particles lodge,” says the FDA.

Potential effects after intravenous administration include local damage to blood vessels in the lung, localized swelling and granuloma formation. Intramuscular injection could result in foreign-body inflammatory response, localized pain and swelling, and possible long-term granuloma formation.

Patients who have any of the recalled lots of methotrexate should immediately discontinue use and contact their health care provider if they experience any problem that could be related to the use of the product. Adverse events can also be reported to Sandoz at 800-525-8747 or to the FDA’s MedWatch Adverse Event Reporting system.

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The recall of methotrexate injection applies to all 50 mg/2mL and 250 mg/10mL vials of the drug.

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

Lot Number and Expiration Dates

  • 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 and Expiration Date

  • 2395703 (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
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