Drug Recall Enforcement Report Class I voluntary initiated by Jacobus Pharmaceutical Company Inc., originally initiated on 09-09-2021 for 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. The product was recalled due to microbial contamination of non-sterile products: firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.. 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.
| Field Name |
Field Value |
| Event ID |
88647 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number |
D-0008-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification |
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. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern |
Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description |
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. What is the Reason for Recall?
Information describing how the product is defective. |
| Product Quantity |
2,324 bottles Product Quantity
The amount of product subject to recall. |
| Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date |
10-06-2021 |
| Recall Initiation Date |
09-09-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. |
| Termination Date |
02-18-2022 What is the Date Terminated?
The date that FDA terminated the recall. |
| Initial Firm Notification |
Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type |
Drugs |
| Recalling Firm |
Jacobus Pharmaceutical Company Inc. |
| Code Info |
Lot #: 18038, 18039, Exp 03/2023; 18079, Exp 05/2023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Status |
Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. |