FDA Recalls Three Lots of Ruzurgi

The affected lots of this rare disease therapy have been contaminated with yeast, mold, and bacteria, which could lead to life-threatening infections.

Jacobus Pharmaceutical Company is voluntarily recalling three lots of Ruzurgi (amifampridine) 10 mg tablets. These lots have been found to be contaminated with yeast, mold, and aerobic bacteria, which could lead to life-threatening infections.

Ruzurgi is used to treat children ages 6 to 17 who have Lambert Eaton Syndrome (LEMS), a rare, autoimmune disease that affects the connection between nerves. This interferes with the ability of nerve cells to send signals to muscle cells, resulting in weakness of the upper legs, upper arms, and shoulders, according to the Muscular Dystrophy Association.

In about 50% to 60% of cases, LEMS is associated with an underlying disease, particularly small cell lung cancer. It is thought that the body’s attempt to fight the cancer inadvertently causes it to attack nerve endings because cancer cells share some of the same proteins as nerve endings.

The estimated worldwide prevalence of LEMS is about 2.8 per million, according to the National Organization for Rare Disorders.

The product affected by the recall is packaged in 100-count bottles with an NDC number of 49938-110-01 with the following control numbers and expiration dates

  • Control Number 18038, Expiration 03/2023
  • Control Number 18039, Expiration 03/2023
  • Control Number 18079, Expiration 05/2023

Ruzurgi was distributed worldwide to specialty pharmacies and physicians.

Jacobus was informed of the contaminated product by its Canadian partner that was conducting confirmatory full testing on Control Number 18038. Jacobus conducted an expanded investigation, which identified Control Numbers 18039 and 18079 as also being contaminated.