Sandoz recalls injectable methotrexate

May 22, 2013

Two lots of Sandoz methotrexate sodium found to contain particulate matter

Sandoz is conducting a voluntary nationwide recall at the U.S. hospital/user level of two lots of its injectable methotrexate sodium, USP, 25 mg/mL, 40 mL vials, as a result of the discovery of particulate matter during routine quality examination of vials included among the manufacturer’s retention samples.

The lot numbers and expiration dates of the two recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). They were distributed nationally across the United States, as well as to Poland.

According to an FDA Safety Announcement, parenteral injection of drug from the affected lots can lead to microembolization in areas where the particles lodge. Clinical symptoms are not to be expected from these microemboli, and Sandoz is unaware of any reports of related adverse events.

“While the [recall] has been reported not to cause significant symptoms related to the development of microembolization, healthcare professionals should be advised to refrain from using these particular lots numbers as the risk of harm resulting from adverse events may greatly outweigh the benefit,” said Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas.

Methotrexate is an antimetabolite used to treat neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program in one of the following ways:

  • Download the reporting form or call 800-332-1088 to request a reporting form; then complete and return it to the address on the preaddressed form or submit it by fax to 800-FDA-0178