FDAClass IIOctober 16, 2019

10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose recall: Sterility Concern

10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13

Why was 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose recalled?

Lack of Assurance of Sterility: 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 #: 87-095-JT Exp. 1MAR2020

Product
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13
Recalling firm
Pfizer Inc.
Quantity
17832 bags
Distribution
Nationwide in the United States and Puerto Rico
Recall date
October 16, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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