March 2013 FDA Recall Drug by Hospira Inc.
D-836-2013 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Hospira Inc. on March 29, 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-836-2013

Reason for Recall
Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
Initiated
03-29-2013
Reported
08-14-2013
Quantity
691,356 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64792
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.
07-20-2015
Product Description About Product Description
Full technical description of the product.
0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.

Batch or Lot Expiration Information

Lot# : 25-037-JT*, Exp 1JAN2015, Note: the lot number may be followed by 01 or 90