Three lots of Ruzurgi, a drug used to treat the autoimmune disease LEMS in children, were recalled by Jacobus Pharmaceutical Co. after testing found contamination by aerobic bacteria, yeast and mold.
“Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in serious and life-threatening infections,” the Jacobus-written, FDA-posted recall notice says. “The use of the defective product in patients with underlying immunosuppressive conditions such as LEMS increases the concern for serious infections.”
What Ruzurgi is recalled?
The recalled Ruzurgi, the brand name for amifampridine, came in 100-count bottles of 10 mg tablets. The lots have control No. 18038, with expiration 03/2023 (distributed only in Canada, where the problem was found); control No. 18039, expiration 03/2023; and control No. 18079, expiration 05/2023.
What should you do with the recalled Ruzurgi?
If you have the pulled Ruzurgi, Jacobus wants you to return it to the company. If using the U.S. Postal Service, send it to Jacobus Pharmaceutical Company, P.O. Box 5290, Princeton, NJ, 08540. If using UPS, DHL or FedEx, send it to Jacobus Pharmaceutical Company, IRL Building, 31 Schalks Crossing Rd., Plainsboro, NJ 08356.
If you have questions about the recall, call Jacobus at 609-799-8221, ext. 2120, Monday thru Friday, 9 a.m. to 5 p.m., Eastern time.
If this or any drug causes a problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088. Only then do you notify the drug company.
What is LEMS?
LEMS stands for “Lambert-Eaton myasthenic syndrome.” It’s an autoimmune disease, meaning the immune system attacks the body.
In the case of LEMS, “the immune system attacks the calcium channels on nerve endings that are required to trigger the release of chemicals (acetylcholine),” the Muscular Dystrophy Association explains. “With fewer calcium channels, the nerve ending releases less acetylcholine. Acetylcholine is a chemical messenger that triggers muscle contraction. In people with LEMS, the lowered levels of acetylcholine are not sufficient to cause normal muscle contractions, causing muscle weakness.”