FDAClass IIMarch 13, 2013

HEXTEND 6% Hetastarch in Lactated Electrolyte Injection recall: Sterility Concern

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

Why was HEXTEND 6% Hetastarch in Lactated Electrolyte Injection 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 10-199-JT Exp. 10/13

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
Recalling firm
Hospira Inc.
Quantity
11,412 bags
Distribution
Nationwide
Recall date
March 13, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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