Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, pa...

FDA Recall #D-1033-2014 — Class II — December 12, 2013

Recall #D-1033-2014 Date: December 12, 2013 Classification: Class II Status: Terminated

Product Description

Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Reason for Recall

Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.

Recalling Firm

Hospira Inc. — Lake Forest, IL

Classification

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

Product Type

Drugs

Product Quantity

126,425 vials

Distribution

Nationwide

Code Information

Lot #: 27-568-DJ*, Exp 03/15, Note * may be followed by 01

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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