FDAClass IIApril 27, 2016

Mannitol I.V recall: Contamination

Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2

Why was Mannitol I.V recalled?

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

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# 52-031-JT, Exp 10/16

Product
Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
Recalling firm
Hospira Inc.
Quantity
22292 bags
Distribution
US: Nationwide and Singapore
Recall date
April 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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