The last Recall Enforcement Report for Dobutamine with NDC 0409-2344 was initiated on 01-10-2014 as a Class I recall due to presence of particulate matter: discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution. The latest recall number for this product is D-1540-2014 and the recall is currently terminated as of 07-14-2015 .
Recall Number D-1540-2014
||67354 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
||D-1540-2014 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
||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".
||Nationwide and Puerto Rico. 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.
||DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02
|Reason For Recall
||Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution. What is the Reason for Recall?
Information describing how the product is defective.
||123,900 vials Product Quantity
The amount of product subject to recall.
||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.
|Recall Initiation Date
||01-10-2014 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
||07-14-2015 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.
||Lot # 27-352-DK; Exp 03/15 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.
|Recalled NDC Packages
||0409-2344-01; 0409-2344-62; 0409-2344-02
||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.
||View Recall Report
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.