FDAClass IIJuly 3, 2013

5% Dextrose Injection USP recall: Sterility Concern

5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045

Why was 5% Dextrose Injection USP recalled?

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

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 #: a) 01-201-JT, Exp 7/12; b) Lot 91-054-JT, Exp 7/12

Product
5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045
Recalling firm
Hospira Inc.
Quantity
267,288 units
Distribution
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Recall date
July 3, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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