FDAClass IAugust 27, 2014

DOBUTamine Injection recall: Particulate Matter

DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC…

Why was DOBUTamine Injection recalled?

Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.

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 # 27-352-DK; Exp 03/15

Product
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC…
Recalling firm
Hospira Inc.
Quantity
123,900 vials
Distribution
Nationwide and Puerto Rico.
Recall date
August 27, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls