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Hospira Recalls Propofol With Glass Vial Defects

Hospira holds the position as the number one provider of injectable drugs worldwide; however, flaws in the production of glass vials have left this powerhouse recalling three lots of propofol. After finding visible particles which had been embedded within the glass vials containing Propofol Injectable Emulsion, 1%, 1g/100 mL, Hospira issued a nationwide recall on August 14, 2012. According to the U.S. Food and Drug Administration, Hospira is recalling the products to protect consumers from possible adverse reactions which may occur if the particles become dislodged from the vial and combine with the solution.

propofol bottle

Adverse Reactions Associated with Recalled Propofol

No adverse reactions have been reported since the release of these products. But, upon injection of the particles, patients may suffer from tissue necrosis (cell death through disease or injury) which can lead to a variety of serious side effects such as a:

  • stroke (a condition in which insufficient oxygen is transported to certain parts of the brain)
  • heart attack
  • decrease in liver or kidney function
  • suppressed respiratory function/ respiratory failure

Propolol Recall Information

Recalled lots include Lot 07-893-DJ with an expiration date of July 1, 2013, and Lots 10-123-DJ and 10-125-DJ with expiration dates of October 1, 2013. Hospira will be mailing consumers with recalled Propofol Injectable Emulsion, 1%, 1 g / 100 mL  for more information about returning and replacing this inventory.

If you have a recalled Propofol product, dial 1-888-410-7509 to call Stericycle and do not use the product. For more questions about the product and health risks, contact Hospira Medical Communications at 1-800-615-0187.

In the event of developing an adverse reaction to an accidental injection of a recalled product, report your case to the FDA MedWatch Program. Contact info for reaching the program by fax, mail or online may be found at http://www.fda.gov/Safety/Recalls/ucm315719.htm.