FDA-Drug2021-10-06Class I
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.
Jacobus Pharmaceutical Company Inc.
Hazard
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Sold states
Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
Affected count
2,324 bottles
Manufactured in
Industrial Research Laboratory Building, 31 Schalks Crossing Rd, Plainsboro, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2022Don't want to check this manually?
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