Jacobus Pharmaceutical Company is recalling 3 lots of Ruzurgi (amifampridine) 10 mg tablets because the products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results.
Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions such as Lambert Eaton Syndrome (LEMS) increases the concern for serious infections.
RECOMMENDATIONS:
Patients that have Ruzurgi (amifampridine) which is being recalled should stop using and return this product.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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