Sandoz Recalls Methotrexate Injections USP

Sandoz Inc. has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product (methotrexate) to the consumer/user level the FDA announced today.

Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product 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 delamination of the glass used to manufacture the vials of these two dosage presentations.

Due to particle size, there is the potential to develop adverse reactions in areas where the particles lodge. While it is unlikely, parenteral 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 administration. Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation. Intra-arterial administration could result in damage to blood vessels in the distal extremities or organs. To date, Sandoz has not received any adverse event reports or product complaints attributable to particles from any lot of methotrexate, including the lots where flakes have been found.

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 presentations of methotrexate. The product lot numbers, label type and expiration dates are listed below as well as on the Sandoz US website at us.sandoz.com. Product : Methotrexate Injection, USP, 50mg/2mL NDC Number : 66758-040-02 (10 vial pack) and 66758-040-01 (Individual vial)

Product : Methotrexate Injection, USP, 250mg/10mL NDC Number : 66758-040-08 (10 vial pack) and 66758-040-07 (Individual vial)

Sandoz has sent out recall letters to inform all distributors, wholesalers and pharmacies of the voluntary recall. The recall is being conducted with the knowledge of the United States Food and Drug Administration (FDA).

Customers and patients should immediately discontinue use of this product and patients should contact their physician or healthcare provider if they experience any problem that might be related to the use of this product. Additionally, as noted in the product's labeling, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

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 either online, by regular mail or by fax:

• Online:www.fda.gov/medwatch/report.htm10
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm11. Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

Customers and patients can arrange for return and reimbursement through GENCO Pharmaceutical Services, the returns vendor for Sandoz, by calling the dedicated Methotrexate Recall Hotline of 1-888-896-4565 or by sending a message to the dedicated Methotrexate Recall Email address of [email protected]. Operators are available 24 hours, seven days per week to provide assistance.