HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTR...
FDA Recall #D-184-2013 — Class II — October 22, 2012
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Recalling Firm
Hospira Inc. — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
11,412 bags
Distribution
Nationwide
Code Information
Lot # 10-199-JT Exp. 10/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated