Drug Used To Treat Rare Autoimmune Disorder Recalled Over Yeast, Mold Contamination

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FDA Food and Drug
The FDA's headquarters and home of the Center for Drug Evaluation and Research in Silver Spring, Maryland.

New Jersey-based Jacobus Pharmaceutical Company is recalling three lots of Ruzurgi (amifampridine) 10-milligram tablets after laboratory tests revealed they may be contaminated with yeast, mold and aerobic bacteria. Usage of such contaminated products may lead to "serious and life-threatening infections."

Jacobus learned of the problem after it was informed by its Canadian partner, which conducted confirmatory testing on Control Number 18038, the announcement posted on the U.S. Food and Drug Administration (FDA) noted. The company then launched further investigations during which they identified two more Control Numbers: 18039 and 18079.

"Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in serious and life-threatening infections," the company announcement noted. "The use of the defective product in patients with underlying immunosuppressive conditions such as Lambert Eaton Syndrome (LEMS) increases the concern for serious infections."

This is of particular concern as Ruzurgi (amifampridine) 10-milligram tablets are actually used to treat LEMS in children ages "6 to less than 17." LEMS is the rare autoimmune disorder wherein the immune system attacks the neuromuscular junctions or the places where the muscles and nerves connect, Johns Hopkins Medicine noted. As such, those with the condition may have difficulty moving their muscles.

First discovered in Scotland in the 1970s, amifampridine has been investigated for its effectiveness in treating neuromuscular disorders, including LEMS, since the 1980s. It is the "non-immune" treatment for LEMS.

Of the products affected by the recall, control numbers 18038 and 18039 have an expiration date of 03/2023, while control number 18079 has an expiry of 05/2023. They come in 100 count bottles where the control numbers can be found below the D2 barcode.

"Ruzurgi (amifampridine) was distributed worldwide to specialty pharmacies and physicians," the announcement noted. Of the three affected control numbers, however, 18038 was distributed from May 25 to Aug. 26 this year in "Canada only."

Those who may have the affected Ruzurgi (amifampridine) products are being advised to stop using them and send them back to the company. Moreover, anyone who may have experienced health issues related to taking the product should contact their healthcare provider.

Those with questions about the recall may contact Jacobus at (609)799-8221 ext. 2120.


FDA Food and Drug

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