FDAClass IISeptember 4, 2013

Ketorolac Tromethamine Inj recall: Sterility Concern

Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01

Why was Ketorolac Tromethamine Inj recalled?

Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop 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?

Lot 25048DK Exp. 01/15

Product
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Recalling firm
Hospira, Inc.
Quantity
345,800 vials
Distribution
Naitonwide
Recall date
September 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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