FDAFDA · Food and drugs·Recall number D-0008-2022
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.
Published October 6, 2021 · Recall initiated: September 9, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Jacobus Pharmaceutical Company Inc.
- Distributor
- Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
- Lot
- Lot #: 18038, 18039, Exp 03/2023; 18079, Exp 05/2023
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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