August 2013 FDA Recall Drug by Hospira Inc.
D-461-2014 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Hospira Inc. on August 30, 2013 for the product Drug. 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-461-2014

Reason for Recall
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Initiated
08-30-2013
Reported
01-22-2014
Quantity
17,256 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66147
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.
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.
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.
08-21-2015
Product Description About Product Description
Full technical description of the product.
Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.

Batch or Lot Expiration Information

Lot# 26-138-JT; Exp. 08/14