October 2012 FDA Recall Hextend by Hospira Inc.
D-184-2013 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Hospira Inc. on October 22, 2012 for the product Hextend. 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-184-2013
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
10-22-2012
03-13-2013
11,412 bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
03-31-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
Batch or Lot Expiration Information
Lot# 10-199-JT Exp. 10/13
