September 2021 FDA Recall Drug by Jacobus Pharmaceutical Company Inc.
D-0008-2022 - Microbial contamination of non-sterile products

This Class I drug recall was voluntarily initiated by Jacobus Pharmaceutical Company Inc. on September 9, 2021 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed in Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only. and the recall is currently terminated.

Recall Number: D-0008-2022

Reason for Recall
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Initiated
09-09-2021
Reported
10-06-2021
Quantity
2,324 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88647
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jacobus Pharmaceutical Company Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-18-2022
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# : 18038, 18039, Exp 03/2023; 18079, Exp 05/2023