FDAClass IIAugust 14, 2013

Ondansetron Injection recall: Particulate Matter

Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.

Why was Ondansetron Injection recalled?

Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot

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 25394DK, exp. 01/2015

Product
Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
Recalling firm
Hospira, Inc.
Quantity
340,600 vials
Distribution
Nationwide
Recall date
August 14, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls