Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (Amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination
September 30, 2021,
Dear Healthcare Provider,
The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by U.S Food and drug Administration (FDA) that Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (Amifampridine) 10 mg tablets to the consumer level. The products were 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.
The product is used as a treatment for LEMS in patients ages 6 to less than 17
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HEALTHCARE PROVIDER’S ACTIONS
NAFDAC implores healthcare professionals, distributors, importers, in possession of the recalled lots of Ruzurgi® (Amifampridine) 10 mg tablets to discontinue sale or use and handover the remaining stock to the nearest NAFDAC office.
Health professionals and patients are encouraged to report adverse events or quality problems experienced with the use of these medicines to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via firstname.lastname@example.org or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety Application available for download on Android and IOS stores.