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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 2,324
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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