FDAClass IIJune 27, 2018

5% Dextrose Injection recall: Sterility Concern

5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02

Why was 5% Dextrose Injection recalled?

Lack of assurance of sterility: Bags have 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?

Lot #: 86-033-JT, Exp 08/01/2019

Product
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
Recalling firm
ICU Medical Inc
Quantity
267288 bags
Distribution
Nationwide and Canada
Recall date
June 27, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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