Drug recall notice for Ruzurgi (amifampridine) 10 mg tablets

A physician holds a vial of pills while taking notes at a computer.

To assist you in the care of your patients, we would like to alert you to the recall of three lots of Ruzurgi® (amifampridine) 10 mg tablets on Sept. 13, 2021.1 We recommend you review your medical records and contact all patients for whom you have prescribed this medication to warn them of the recall.

The drug manufacturer, Jacobus Pharmaceutical Company Inc., is voluntarily recalling three lots of this drug, which is prescribed as treatment for Lambert-Eaton myasthenic syndrome (LEMS). The drugs are being recalled because they were found to be contaminated with yeast, mold and aerobic bacteria. Patients with LEMS who receive these drugs may have an increased risk for serious and life-threatening infections due to their underlying condition.

Other lot numbers of Ruzurgi that are not affected by this recall are available.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Medications included in this recall

Product name NDC number Lot number Expiration date Ruzurgi 10 mg 4993811001 18038 03/2023 Ruzurgi 10 mg 4993811001 18039 03/2023 Ruzurgi 10 mg 4993811001 18079 05/2023

Information for providers:1

  • We have sent a letter to your Humana-covered patients who have had a claim for Ruzurgi and asked them to contact their physicians or healthcare providers if their medication is included in the recall and if they have experienced problems that may be related to using these drug products.
  • Healthcare professionals with questions regarding this recall can contact Jacobus Pharmaceutical Company Inc. by phone at 609-799-8221, ext. 2120, Monday – Friday, 9 a.m. – 5 p.m., Eastern time.
  • Patients may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
    • Online: Complete and submit the report .
      • Select “Consumer/Patient (FDA Form 3500B).”
    • Regular mail or fax: Download the form .
      • Select “Form FDA 3500B – Voluntary Reporting for Consumers” and submit by mail to the address on the form or by fax to 800-FDA-0178 (332-0178).

Reference:

  1. “Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination,” U.S. Food and Drug Administration, last accessed Sept. 21, 2021, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jacobus-pharmaceutical-company-inc-issues-voluntary-worldwide-recall-ruzurgir-amifampridine-10-mg?utm_medium=email&utm_source=govdelivery, opens in new window.