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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ruzurgi (amifampridine) Tablets Recalled for Microbial Contamination

Agency Publication Date: September 29, 2021
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Summary

Jacobus Pharmaceutical Company Inc. is recalling 2,324 bottles of Ruzurgi (amifampridine) 10 mg tablets because company testing found levels of bacteria, yeast, and mold that exceed safety limits. Ruzurgi is a prescription medication used to treat a rare muscle disease called Lambert-Eaton Myasthenic Syndrome. No injuries or illnesses have been reported to date, but the company is taking this voluntary action as a precaution. Patients should contact their doctor or pharmacist to discuss their treatment options while this recall is underway.

Risk

Taking medication contaminated with bacteria, yeast, or mold can cause serious infections or other adverse health reactions, particularly in patients with weakened immune systems. No incidents have been reported, but the elevated microbial counts found during testing pose a potential safety risk to consumers.

What You Should Do

  1. This recall affects Ruzurgi (amifampridine) 10 mg tablets packaged in 100-count bottles with NDC 49938-110-01.
  2. Identify if your bottle is included by checking for lot numbers 18038 or 18039 (both with expiration date 03/2023) or lot number 18079 (with expiration date 05/2023).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Jacobus Pharmaceutical Company Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information regarding this alert.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Ruzurgi (amifampridine) Tablets 10 mg (100-count bottle)
Variants: 10 mg, Tablet
Lot Numbers:
18038 (Exp 03/2023)
18039 (Exp 03/2023)
18079 (Exp 05/2023)
NDC:
49938-110-01

Lot 18038 was distributed to Canada only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88647
Status: Resolved
Manufacturer: Jacobus Pharmaceutical Company Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2,324 bottles
Distributed To: Nationwide
Agency Last Updated: October 8, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.