Jacobus Pharmaceutical Company is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10mg tablets due to yeast, mold, and aerobic bacterial contamination based laboratory test results.
The 3 recalled lots of Ruzurgi 10mg tablets; NDC 49938-110-01, were distributed worldwide to specialty pharmacies and physicians, and include the following:
- Control Number 18038; Expiration Date 3/2023; Distributed between 5/25/2021 – 8/26/2021 (Canada only);
- Control Number 18039; Expiration Date 3/2023; Distributed between 6/1/2021 – 8/10/2021;
- Control Number 18079; Expiration Date 5/2023; Distributed between 8/10/2021 – 8/30/2021.
Ruzurgi is a potassium channel blocker indicated for the treatment of Lambert Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. According to the Company, use of the recalled product in patients with LEMS increases the risk of serious and life-threatening infections.
Adverse events associated with the recall should be reported to the Food and Drug Administration’s MedWatch program.
For more information contact Jacobus Pharmaceutical Company by calling (609) 799-8221, Extension 2120.
Jacobus Pharmaceutical Company Inc. issues voluntary worldwide recall of Ruzurgi® (amifampridine) 10 mg tablets due to yeast, mold, and bacterial contamination. News release. US Food and Drug Administration. Accessed September 14, 2021. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jacobus-pharmaceutical-company-inc-issues-voluntary-worldwide-recall-ruzurgir-amifampridine-10-mg.