FDA recall D-0008-2022

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-09-09

Report date

2021-10-06

Termination date

2022-02-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2022