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September 13, 2021 – Jacobus Pharmaceutical Company recalled three lots of Ruzurgi® (amifampridine) 10mg tablets. Laboratory test found that the affected lots are contaminated with yeast, mold, and aerobic bacteria (bacteria that require oxygen to survive).
- There is no impact to members through Benecard Central Fill.
- Ruzurgi is FDA-approved to treat Lambert-Eaton myasthenic syndrome (LEMS) in individuals six years to less than 17 years old. Treatment of LEMS, an autoimmune disease, may also include the use of drugs that suppress the immune system.
- Oral products heavily contaminated with yeast, mold, and aerobic bacteria can cause serious, potentially life-threatening infections. The risk is higher in immunocompromised individuals, such as children diagnosed with LEMS.
- Jacobus advises consumers who have Ruzurgi belonging to the following lots to stop using it
immediately:
- Control Number 18038, distributed between 05/25/2021 – 08/26/2021 (Canada only)
- Control Number 18039, distributed between 06/01/2021 – 08/10/2021
- Control Number 18079, distributed between 08/10/2021 – 08/30/2021
- Consumers can return the recalled Ruzurgi to:
- If shipping via US Postal Service:
Jacobus Pharmaceutical Company, Inc.
P.O. Box 5290, Princeton, NJ 08540. - If shipping via UPS, FedEx, or another courier service:
Jacobus Pharmaceutical Company, Inc.
IRL Building
31 Schalks Crossing Road
Plainsboro, NJ 08356.
- If shipping via US Postal Service:
- Questions regarding the recall should be directed to Jacobus at 1-609-799-8221, ext. 2120. If a consumer has experienced any problems that may be related to use of the affected Ruzurgi, Jacobus recommends they contact their healthcare provider.
- A full copy of the recall announcement is available on the FDA's website.