Hospira announces nationwide recall of propofol injectable emulsion
Hospira Inc., the world's leading provider of injectable drugs and infusion technologies, announced a nationwide recall of three lots of propofol injectable emulsion 1%, 1g/100mL.
The recall was due to visible particles embedded in the glass to the user level. There is the possibility that the product may come into contact with the embedded particles, allowing the particles to become dislodged into the solution.
Medical intervention may be required if the particulate matter is injected into a patient, causing injury. Risks associated with the glass vial 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.
Hospira has received no reports of adverse effects related to these lots. Preliminary investigation analysis has identified the root cause as a supplier glass defect. Hospira is working with the glass vial supplier to determine the cause of the defect.
Propofol injectable emulsion is packaged in vials and used 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: 0409-4699-24, 07-893-DJ, expiration July 1, 2013 and 10-123-DJ, 10-125-DJ, expiration date Oct. 1, 2013.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. The recall is a precautionary measure.
Hospira is making arrangements for the return and replacement 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 between 8 a.m. and 5 p.m., Monday through Friday at 1-888-410-7509 to make arrangements to return the product.
Customers can call Hospira customer care between 8 a.m. and 5 p.m., Monday through Friday at 1-877-976-7747 to ask about product availability.
For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.
Report any adverse reactions or quality problems with these products to the Federal Drug Administration's MedWatch Adverse Events Program. They can be contacted online by visiting fda.gov/medwatch/report/report.htm or by fax at 1-800-FDA-0178. They can also be contacted by regular mail, by sending the form available online at fda.gov/MedWatch/getforms.htm to 10903 New Hampshire Ave., Silver Spring, MD 20993.
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