FDAClass IIDecember 8, 2021

5% Dextrose Injection recall: Sterility Concern

5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66

Why was 5% Dextrose Injection recalled?

Lack of sterility assurance: bag has 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?

Lot: 4923608 Exp. 1MAY2022

Product
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66
Recalling firm
Pfizer Inc.
Quantity
765 bags
Distribution
USA Nationwide
Recall date
December 8, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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