Ruzurgi Tablets 10 mg recalled over sterility concerns

Recall date

September 9, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Jacobus Pharmaceutical Company Inc. recalls Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical…

Recall number

D-0008-2022

FDA classification

Class I

Brand / firm

Jacobus Pharmaceutical Company Inc.

Sold / distributed

Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.

Why it was recalled

Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.