FDAnews Device Daily Bulletin

Watson Announces Limited Recall of Fentanyl

Aug. 12, 2008

Watson Pharmaceuticals is voluntarily recalling one lot of 75 mcg/hr fentanyl transdermal system patches sold in the U.S. from wholesalers and pharmacies.

A small number of patches leaking fentanyl gel have been detected in this lot, which may expose people directly to the gel and lead to serious adverse events such as respiratory depression or possible overdose.

The affected patches were shipped to customers between Jan. 30 and March 19. No other strengths or lots were affected, and the company does not anticipate any product shortages as a result of this recall. The company has notified the FDA, Watson said.