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Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx ...

FDA Recall #D-1672-2012 — Class II — August 3, 2012

Recall #D-1672-2012 Date: August 3, 2012 Classification: Class II Status: Terminated

Product Description

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 0409-4699-24

Reason for Recall

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

Recalling Firm

Hospira Inc. — Lake Forest, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

56,420 vials

Distribution

Nationwide

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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