Ruzurgi (amifampridine) Tablets Recalled for Microbial Contamination
Jacobus Pharmaceutical Company is recalling Ruzurgi (amifampridine) 10 mg tablets due to microbial contamination. Testing found that certain lots exceeded acceptable limits for aerobic bacteria, yeast, and mold.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I by the issuing agency, which mandates a minimum score of 4 per the severity rubric. Microbial contamination of non-sterile pharmaceutical products presents a significant risk of harm even absent reported illnesses.
Plain-English summary
Jacobus Pharmaceutical Company, Inc. is recalling Ruzurgi (amifampridine) Tablets 10 mg in 100-count bottles (NDC 49938-110-01) due to microbial contamination. The company's testing identified lots that exceeded specification limits for aerobic bacteria, yeast, and mold counts.
The affected lots are: #18038 and #18039 (expiration 03/2023), and #18079 (expiration 05/2023). Approximately 2,324 bottles were distributed within the USA and Canada. Lot #18038 was distributed to Canada only.
Patients taking this recalled medication should contact their healthcare provider or pharmacist for guidance. Do not stop taking the medication without consulting a healthcare professional, as abrupt discontinuation may cause harm.
The recalled product
- Product
- Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.
- Manufacturer
- Jacobus Pharmaceutical Company Inc.
- Category
- Drug — Prescription Tablet
- Hazard
- microbial-contamination
- aerobic-bacteria
- yeast
- mold
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: 18038
- 18039
- Exp 03/2023
- 18079
- Exp 05/2023
Distribution
Distribution scope not specified by the agency.
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