FDAClass IISeptember 5, 2012

Propofol Injectable Emulsion recall: Particulate Matter

Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC…

Why was Propofol Injectable Emulsion recalled?

Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.

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?

07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013

Product
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC…
Recalling firm
Hospira Inc.
Quantity
56,420 vials
Distribution
Nationwide
Recall date
September 5, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls