FDAClass IINovember 27, 2013

Ondansetron Injection recall

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03

Why was Ondansetron Injection recalled?

Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.

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?

29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)

Product
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03
Recalling firm
Hospira Inc.
Quantity
681,400 vials
Distribution
Nationwide and Puerto Rico
Recall date
November 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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