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Hospira Recalls Anesthesia Drug

Bedram Bararpour4 years ago

Pharmaceutical and medical device-maker Hospira is recalling three lots of Propofol Injectable Emulsion due to the presence of visible particles embedded in the glass vials.

If the product were to come into contact with the visible particles, there is a risk that the particulate matter could be injected into a patient. Propofol is often used to maintain anesthesia in surgical patients.

Defect Could Cause Life-Threatening Risks

According to the U.S. Food and Drug Administration (FDA), if the particulate matter is injected into a patient, the patient could be at risk of serious injury requiring medical intervention. The potential risks include tissue necrosis that could lead to:

The Root Cause of the Defect

  • 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.
  • It is recommended that anyone who has an inventory of the recalled products stop the use and distribution of the product, quarantine the product immediately, and call Stericycle to arrange for the return of the product.
  • Contact information for Stericycle can be found on the official recall notice.
Description of the Recalled Propofol

Information below provided by the U.S. FDA.

  • The recalled lots were distributed nationwide to wholesalers and direct customers from Sept. 2011 through Feb. 2012.
  • The full product name is Propofol Injectable Emulsion, 1%, 1 g / 100 mL (10 mg/mL).
  • The NDC Number of the product is 0409-4699-24.
  • The affected lots are 07-893-DJ (expiration date is 07-1-2013), 10-123-DJ (expiration date is 10-1-2013), and 10-125-DJ (expiration date is 10-1-2013).
Contact an Experienced Product Liability Attorney

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If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.


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