Sandoz Recalls 50mg/2mL and 250mg/10mL Vials of Methotrexate Injection Due to Glass Particulates

The following recall is being posted as some veterinarians may use this product in treating their patients.

Customer Service: (800) 525-8747
Web site: www.us.sandoz.com

Sandoz Inc. has recalled all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product (“methotrexate”) to the consumer/user level. 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:

Product : Methotrexate Injection, USP, 50mg/2mL

NDC Number : 66758-040-02 (10 vial pack) and 66758-040-01 (Individual vial)

Lot Number
Label Type
Exp Date
92395606Parenta12/2010
92760803Parenta2/2011
92965104Parenta3/2011
92965106Parenta3/2011
92965904Parenta4/2011
93255704Parenta6/2011
93502204Parenta7/2011
93635404Parenta8/2011
93681704Parenta8/2011
93794904Sandoz9/2011
95198604Sandoz10/2011
95357804Sandoz12/2011
95537704Sandoz1/2012
95987004Sandoz3/2012

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

Lot Number
Label Type
Exp Date
92395703Parenta12/2010
92760903Parenta2/2011
92965203Parenta3/2011
92966003Parenta4/2011
93255803Parenta6/2011
93502303Parenta7/2011
93635503Parenta8/2011
93795003Sandoz9/2011
95198703Sandoz10/2011
95357903Sandoz12/2011

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.

Published: October 28, 2010;    Updated: October 28, 2010

Filed Under: Recalls Warnings

Author: Oregon Veterinary Medical Association

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