PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 13, 2013 Initiated: October 22, 2012 #D-184-2013

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.

Details

Recalling Firm
Hospira Inc.
Units Affected
11,412 bags
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Hospira Inc.. Units affected: 11,412 bags.
Why was this product recalled?
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 13, 2013. Severity: Moderate. Recall number: D-184-2013.