FDAClass IINovember 14, 2018

5% Dextrose Injection recall: Sterility Concern

5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045

Why was 5% Dextrose Injection recalled?

Lack of Assurance of Sterility; bags have the potential to leak

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?

Lots: a) 84-017-JT Exp. December 01, 2019; b) 84-012-JT Exp. June 01, 2019

Product
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
Recalling firm
ICU Medical Inc
Quantity
372,912 bags
Distribution
Nationwide.
Recall date
November 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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