FDAClass IIAugust 21, 2013

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, NDC…

Why was Propofol Injectable Emulsion recalled?

Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel

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 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013

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, NDC…
Recalling firm
Hospira Inc.
Quantity
94,110 vials
Distribution
Nationwide
Recall date
August 21, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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