FDAClass IIMay 1, 2013

Propofol Injectable Emulsion recall: Particulate Matter

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC…

Why was Propofol Injectable Emulsion recalled?

Presence of Particulate Matter: A single visible particulate was identified during a retain sample 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?

Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02

Product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC…
Recalling firm
Hospira Inc.
Quantity
245,250 vials
Distribution
Nationwide and Puerto Rico
Recall date
May 1, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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