June 2013 FDA Recall Drug by Hospira Inc.
D-608-2013 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Hospira Inc. on June 6, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-608-2013

Reason for Recall
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Initiated
06-06-2013
Reported
06-26-2013
Quantity
676,872 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65400
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.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2015
Product Description About Product Description
Full technical description of the product.
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02

Batch or Lot Expiration Information

Lot# : 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02