Teva Propofol Recall Leads to FDA Warning, Drug Shortage

Teva Pharmaceuticals failed to have proper quality control measures in place to prevent bacterial contamination from entering batches of their generic version of the anesthetic propofol, leading to a recall last year after at least 40 people became ill, according to federal inspectors. 

The FDA published a warning letter to Teva this week regarding its propofol manufacturing facility in Irvine, California, following inspections that coincided with a Teva propofol recall issued in July 2009. FDA inspectors found a number of deficiencies, particularly in areas required to keep contaminants out of medications, which they say Teva has failed to properly address since the incident.

More than 57,000 vials of Teva-manufactured propofol were recalled after the U.S. Centers for Disease Control and Prevention (CDC) issued a health advisory on July 13, 2009, warning physicians not to use 100 ml vials of propofol from two lots. Some patients, particularly those undergoing endoscopy, were discovered to have febrile reactions to the medication and were found to be positive for elevated levels of endotoxin.

Propofol, a generic version of AstraZeneca’s Diprivan, is a short-acting anesthesia medication which is used for sedation during medical procedures, such as colonoscopy and endoscopy, as well as in dental surgery. Teva Pharmaceuticals says it no longer makes propofol, but it is widely available from other generic drug manufacturers.

In the warning letter, FDA inspectors say Teva failed to check raw materials properly for contaminants. The company also detected high levels of bacterial endotoxin contamination in three vials of propofol, could not find the source, and then allowed that lot to go out anyway, the letter states. That lot was later recalled.

Teva responded to the initial inspection reports with a list of proposed changes in August; however, the new letter says that most of those changes are inadequate.

The Teva propofol recall, and another propofol recall by Hospira, Inc. due to particulate matter contamination in November, has caused a shortage of propofol in the United States. As a result, the FDA has given APP Pharmaceuticals Inc. permission to import Propoven, a similar drug, into the U.S. Propoven has not been approved by FDA, but is in use in a number of other countries around the world.