August 2016 FDA Recall Drug by Hospira Inc.
D-1500-2016 - Discoloration

This Class II drug recall was voluntarily initiated by Hospira Inc. on August 15, 2016 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-1500-2016

Reason for Recall
Discoloration: Firm received complaints of product discoloration and particulates.
Initiated
08-15-2016
Reported
09-21-2016
Quantity
24000 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74707
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Product was distributed nationwide. 23700 units distributed to US and Puerto Rico, and Bahamas was 300 units. 30 units returned by customer and destroyed internally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-23-2019
Product Description About Product Description
Full technical description of the product.
DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20

Batch or Lot Expiration Information

Lot# : 52175DD, Exp 01 Oct 2016