March 2016 FDA Recall Drug by B. Braun Medical Inc
D-0094-2017 - Non-Sterility

This Class I drug recall was voluntarily initiated by B. Braun Medical Inc on March 25, 2016 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0094-2017

Reason for Recall
Non-Sterility: fungal contamination due to leaking containers.
Initiated
03-25-2016
Reported
10-19-2016
Quantity
57,408 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73626
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-12-2016
Product Description About Product Description
Full technical description of the product.
5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32

Batch or Lot Expiration Information

Lot# : J5J706, Exp. 10/31/2016