August 21, 2012
Hospira initiated a nationwide recall of three lots of propofol injection, 1%, 1g/100 ml
(NDC 0409-4699-24) due to a defect in the glass vials. The following 3 lot numbers, which were distributed nationwide from September 2011 to February 2012, are affected by the recall:
- 07-893-DJ (expiration date: 07/01/2013)
- 10-123-DJ (expiration date: 10/01/2013)
- 10-125-DJ (expiration date: 10/01/2013)
Visible particles were found in the glass that may come into contact with the emulsion. If these particles became dislodged and entered the emulsion, there is a possibility they could be injected into a patient. Inadvertent injection of particulate matter could result in tissue necrosis in various organs in the body and could lead to myocardial infarction, respiratory failure, stroke, and renal or hepatic dysfunction. There have not been any adverse events related to the recall reported at this time. Hospira has issued a press release which may be accessed through the link below.
Do not use propofol injection from these affected lot numbers. Call Stericycle (1-888-410-7509) for instructions on returning the product to the manufacturer. Call Hospira Medical Communication (1-800-615-0187) for medical questions related to the recall. Report any adverse events from these products to FDA’s MedWatch Adverse Events Program.
Additional information is available at the following links:
- MedWatch Safety Alert:
- Press Release:
August 21, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.