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Due to Particulate Matter in Vials, Sandoz Recalls Lots of Injectable Methotrexate Sodium

May 21, 2013

Sandoz is conducting a voluntary nationwide recall of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product. This is due to the discovery of particulate matter in vials during a routine quality examination of retention samples at the manufacturing facility, according to the U.S. Food and Drug Administration (FDA).

Methotrexate is an antimetabolite, which is a chemical typically used in the treatment of cancer or as an antibiotic.

The lot numbers and expiration dates of the two recalled lots are: CL0996 (expiration date: December 2013) and CJ4948 (expiration date: May 2013), according to the FDA. Both were distributed nationally and to one foreign country: Poland.

Intravenous injections of drugs taken from affected lots can lead to particles getting lodged, which can cause microembolisation, the FDA added.

If a patient does experience an adverse reaction or quality problem involving this product, they should immediately contact their healthcare professional, as well as Sandoz to report the finding. The Sandoz Drug Information Direct Line is 800-525-2492; it is open 24 hours a day, seven days a week.

The FDA encourages healthcare professionals and patients to also report adverse events or side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program, which can be done in one of several ways:

  • Complete and submit the report online:
  • Download a form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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