August 2012 FDA Recall Drug by Hospira Inc.
D-922-2013 - Presence of Particulate Matter; product may contain fibrous material

This Class I drug recall was voluntarily initiated by Hospira Inc. on August 31, 2012 for the product Drug. The FDA reported the reason for recall as presence of particulate matter; product may contain fibrous material. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-922-2013

Reason for Recall
Presence of Particulate Matter; product may contain fibrous material
Initiated
08-31-2012
Reported
09-04-2013
Quantity
264,432 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63364
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-28-2015
Product Description About Product Description
Full technical description of the product.
0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23

Batch or Lot Expiration Information

Lot# Lot Number 05-201-JT, Expiration Date 1MAY2013