On May 20, 2013, Sandoz announced a voluntary nationwide recall of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US. The withdrawal was made due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. Methotrexate is used to treat neoplastic diseases, severe psoriasis, and rheumatoid arthritis.
Possible Risks Involved
Particulate matter is a potential health hazard, and an injection from the affected lots can lead to microembolisation. The company’s number one priority is the well-being of it’s patients, and the FDA is aware of the recall. Sandoz is not aware of any reports of related adverse events.
What Products Are Affected
The lots were distributed nationally across the United States. The lot numbers of the recalled items are CL0996 and CJ4948.
Reporting A Problem
Patients experiencing adverse reactions or quality problems involving the product should report to their healthcare professional and to Sandoz. The Sandoz Drug Information can be reached at 800-525-2492 (Monday-Sunday, 24/7) or emailed at qa.druginfo@sandoz.com.
Any adverse reactions or quality problems experienced with the use of this product may be reported to the US Food and Drug Administration’s (FDA) MedWatch Adverse Events Program either online, by regular mail, or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm
- Fax: 1-800-FDA-0178