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Hospira Propofol Injectable Emulsion: Recall - Glass Vial Defect

August 17th, 2012

Hospira and FDA have notified healthcare professionals of a nationwide recall of three lots of Propofol Injectable Emulsion, 1%, 1g/100 mL, due to visible particles embedded in the glass to the user level. There may be potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. In the event particulate matter could be injected into a patient, there may be the potential for patient injury where medical intervention may be required. Risks associated with this defect could include tissue necrosis in one or more organs that could result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function. Because pharmacists and other healthcare providers can visually identify the presence of an overfilled Carpuject pre-filled cartridge, FDA is recommending that these steps be taken at this time rather than a product recall, because a recall of the affected products would result in an immediate shortage.

The product is packaged in vials and indicated for the induction or maintenance of anesthesia in surgical patients or to initiate sleep in intensive care units. The affected lots were distributed nationwide to wholesalers and direct customers from September 2011 through February 2012. Hospira has issued a recall letter to U.S. customers voluntarily recalling the following lots:

Product

NDC Number

Lot

Expiration Date

Propofol Injectable Emulsion, 1%,
1 g / 100 mL (10 mg/mL)

0409-4699-24

07-893-DJ

01JUL2013

10-123-DJ

01OCT2013

10-125-DJ

01OCT2013

This recall is being conducted as a precautionary measure. The company is notifying its distributors and customers by letters and is arranging for return/replacement etc. of all recalled products. Anyone with an existing inventory in the United States should stop use and distribution, quarantine the product immediately and call Stericycle at 1-888-410-7509, between the hours of 8 a.m. to 5 p.m. EDT, Monday through Friday, to arrange for the return of the product. Customers can call Hospira Customer Care at 1-877-946-7747, between the hours of 8 a.m. to 5 p.m. CDT, Monday through Friday, to inquire about product availability.

For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week. Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Events Program either online, by regular mail or by fax.