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.

FDA recall notice · announced October 6, 2021 · Jacobus Pharmaceutical

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
Lot/code information: Lot #: 18038, 18039, Exp 03/2023; 18079, Exp 05/2023
Quantity: 2,324 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0008-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.