Jacobus Pharmaceutical Company Inc. recalls Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical C
Recalled October 6, 2021 · FDA recall D-0008-2022 · Jacobus Pharmaceutical
Hazard
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts. · FDA Class I
Units
2,324 bottles
Sold at
Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
Description
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
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(s)
Jacobus Pharmaceutical Company Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →