November 2014 FDA Recall Drug by Hospira Inc.
D-0313-2015 - Discoloration

This Class III drug recall was voluntarily initiated by Hospira Inc. on November 25, 2014 for the product Drug. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0313-2015

Reason for Recall
Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
Initiated
11-25-2014
Reported
12-31-2014
Quantity
3,306 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69900
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira 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.
12-15-2016
Product Description About Product Description
Full technical description of the product.
Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured by Hospira Australia 1 Lexia Place, Mulgrave, Victoria Australia 3170. NDC 61703-327-22.

Batch or Lot Expiration Information

Lot# : B032223AA; Exp: July 2016