14 June 2013

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 June 14, 2013
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injectible methotrexateThe United States Food and Drug Administration recently reported that two lots of injectable methotrexate sodium have been recalled. Particulate matter was discovered during routine quality checks by the manufacturer Sandoz Inc. The lots in question were distributed throughout the United States and in Poland.

Lot Information for Methrotrexate Recall

The lot CL0996 consisted of 6,000 units. Out of these vials, 1,511 have been distributed to the public while the remaining vials are currently on hold. According to the vice president of Communications of the manufacturer who produced the vials informed the public that the lot was distributed in December 2012 through May 2013. The vice president stated that the second lot, CJ4948, consisted of 124 units, all of which were distributed throughout the United States.

Reason for the Methotrexate Recall

Although the particulates that were found in the lots are not associated with microbial contamination, the particulate matter in the medicine is considered by the manufacturer to be a “potential health hazard.”

If the injection is parenteral and comes from an affected lot, microembolisation can occur in the locations in the body where the particles eventually lodge. The manufacturer believes that the injections could cause damage to the lungs. Administration of the contaminated product can also result in particles lodging in areas of spinal fluid resorption if it used as for injections near membranes associated with the brain and spinal cord.

The manufacturer has not received any reports related to adverse effects regarding these lots. However, if a person does experience an adverse reaction regarding the product, they should immediately consult with a healthcare professional, suggests the Food and Drug Administration.

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