October 2013 FDA Recall Cefepime Hydrochloride And Dextrose by B. Braun Medical Inc
D-1054-2014 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by B. Braun Medical Inc on October 15, 2013 for the product Cefepime Hydrochloride And Dextrose. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1054-2014

Reason for Recall
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
Initiated
10-15-2013
Reported
02-12-2014
Quantity
18,936 Containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66497
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.
B. Braun Medical 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2014
Product Description About Product Description
Full technical description of the product.
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11

Batch or Lot Expiration Information

Lot# Lot H3A744, Exp 01/15

Affected Packages Involved in this Recall

0264-3193-11 Cefepime Hydrochloride And Dextrose
0264-3195-11 Cefepime Hydrochloride And Dextrose