Jacobus Initiates Recall of Ruzurgi Lots Over Contamination
Jacobus Pharmaceutical has recalled three lots of Ruzurgi (amifampridine) 10-mg tablets, which were found to be contaminated with yeast, mold and aerobic bacteria based on laboratory tests, the company said in a notice posted by the FDA.
Ruzurgi is approved for use in pediatric patients with the rare neuromuscular disorder Lambert Eaton Syndrome (LEMS), an autoimmune disease that attacks the connection between nerve and muscle, causing weakness in the arms and legs. The company noted that injection from yeast, mold and aerobic bacteria can be particularly harmful in such immunosuppressed populations and “may result in serious and life-threatening infections.”
Jacobus said it was informed of the issue by its Canadian partner that was conducting confirmatory testing on a specific lot (number 18038). Jacobus conducted an expanded investigation and identified further contamination in lot numbers 18039 and 18079, the company said. The medicines were distributed between May 25 and Aug. 30 of this year in 100-count bottles.
Jacobus said consumers that have Ruzurgi from those three lot numbers should stop using it and return it. The company is notifying its distributors and customers and is arranging for return of all recalled products.