A drug used to treat a rare autoimmune disorder has been recalled due to mold and yeast contamination.
After laboratory tests revealed that three lots of Ruzurgi (amifampridine) 10-milligram tablets may be contaminated with yeast, mold, and aerobic bacteria, Jacobus Pharmaceutical Company of New Jersey is recalling them. The use of tainted items could result in “serious and life-threatening diseases.”
The error was discovered after Jacobus was notified by its Canadian partner, who did confirmatory testing on Control Number 18038, according to a statement on the FDA’s website. Following that, the corporation began more investigations, which resulted in the discovery of two more Control Numbers: 18039 and 18079.
Oral items contaminated with yeast, mold, and aerobic bacteria can cause serious and life-threatening infections, according to the business. “Using the faulty product in individuals with underlying immunosuppressive disorders like Lambert Eaton Syndrome (LEMS) raises the risk of catastrophic infections.”
This is especially concerning because Ruzurgi (amifampridine) 10-milligram tablets are intended to treat LEMS in children aged “six to seventeen.”
According to Johns Hopkins Medicine, LEMS is a rare autoimmune illness in which the immune system assaults the neuromuscular junctions, or the points where muscles and nerves link. As a result, persons who suffer with the illness may find it difficult to move their muscles.
Since the 1980s, amifampridine has been studied for its efficacy in treating neuromuscular disorders, including LEMS, after it was first found in Scotland in the 1970s. It is a “non-immune” LEMS treatment.
Control numbers 18038 and 18039 on the recalled products have an expiration date of 03/2023, while control number 18079 has an expiration date of 05/2023. The control numbers can be found below the D2 barcode on the 100 count bottles.
According to the release, “Ruzurgi (amifampridine) was delivered worldwide to specialized pharmacies and physicians.” However, of the three compromised control numbers, 18038 was distributed in “Canada only” from May 25 to August 26 this year.
Those who may have the affected Ruzurgi (amifampridine) products should stop using them and return them to the manufacturer. Furthermore, anyone who has had health problems as a result of using the product should consult their doctor.
Jacobus can be reached at (609)799-8221 ext. 2120 if you have any questions concerning the recall.