FDAClass IIFebruary 4, 2015

Propofol Injectable Emulsion recall: Particulate Matter

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration…

Why was Propofol Injectable Emulsion recalled?

Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

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 35-844-DJ, Exp 11/01/2015

Product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration…
Recalling firm
Hospira Inc.
Quantity
126,075 vials
Distribution
Nationwide
Recall date
February 4, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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