Safety Alerts & Recalls

What does this mean?

If you have recently received an injection of methotrexate or are currently receiving injections of methotrexate, you should contact your doctor or healthcare provider if you experience any problems that might be related to the use of this recalled product, such as any unusual pain or swelling after a methotrexate injection.

If you are receiving methotrexate injections in your home, please check your supply to see if you have any of the recalled product. If you think you have some of the recalled product, please stop using the recalled product and follow up with your doctor, pharmacist, or other healthcare provider to get a replacement. You can also call the Methotrexate Recall Hotline 1-888-896-4565 or send an email message to the dedicated Methotrexate Recall Email address of Sandoz.methotrexaterecall@gencopharma.com to arrange for product return and refund or to ask questions about the recall.

Adverse events related to the use of Sandoz Methotrexate product should be reported to Sandoz at 1-800-525-8747 or to the FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Sandoz Issues Voluntary Recall of Methotrexate Injection Vials

Sandoz Inc. announced it has started a voluntary recall of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection to the consumer/user level. Sandoz is issuing this recall following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots. The flakes are the result of a defect of the glass used to manufacture the vials of these two dosage forms. Due to particle size, there is the potential to develop adverse reactions in areas where the particles lodge in the body. While it is unlikely, injection of drug from the affected lots could lead to serious adverse events. To date, Sandoz has not received any adverse event reports or product complaints related to particles from any lot of methotrexate, including the lots where flakes have been found. As a precaution, Sandoz is recalling a total of 24 lots of Methotrexate Injection.

Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. The affected products are only the 50mg/2mL and 250mg/10mL vials of Methotrexate manufactured by Sandoz and Parenta. This recall does not involve methotrexate tablets that are taken by mouth The recalled product lot numbers are listed below: Methotrexate Injection, USP, 50mg/2mL: 92395606, 92760803, 92965104, 92965106, 92965904, 93255704, 93502204, 93635404, 93681704, 93794904, 95198604, 95357804, 95537704, and 95987004

Methotrexate Injection, USP, 250mg/10mL: 92395703, 92760903, 92965203, 92966003, 93255803, 93502303, 93635503, 93795003, 95198703, and 95357903

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Source: Manufacturer
Publication Date: 2010-10-29
Last Updated: 2010-10-29

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