FDAClass IIJune 12, 2013

DOBUTamine in 5% Dextrose Injection recall: Sterility Concern

DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32

Why was DOBUTamine in 5% Dextrose Injection recalled?

Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.

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 11-309-KL

Product
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
Recalling firm
Hospira Inc.
Quantity
44,748 bags
Distribution
Nationwide and Puerto Rico
Recall date
June 12, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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