FDA Recall Cefoxitin And Dextrose

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Cefoxitin And Dextrose with NDC 0264-3125 was initiated on 11-21-2013 as a Class I recall due to presence of particulate matter: b. braun medical inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. The latest recall number for this product is D-1264-2014 and the recall is currently terminated as of 12-04-2014 .

Recall Number D-1264-2014

Field Name Field Value
Event ID 66913 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-1264-2014 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 Nationwide, Puerto Rico and Spain 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 Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11
Reason For Recall Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 22,584 units 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 05-07-2014
Recall Initiation Date 11-21-2013 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 12-04-2014 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 B. Braun Medical Inc
Code Info Lot# H3E507, Exp 11/14 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 0264-3123-11; 0264-3125-11
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.
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.