Watson announces limited recall of pain patches

The recalled patches are from lot number 92461850, have expiration dates of August 31, 2009 and were manufactured by Watson Laboratories. The affected lot of fentanyl transdermal system patches was shipped to customers between January 30, 2008 and March 19, 2008. No other strengths or lots were affected and the company does not anticipate any product shortages as a result of this recall. The company said that it has notified the FDA of the recall.

A small number of patches leaking fentanyl gel have been detected in this lot, potentially exposing patients or caregivers directly to fentanyl gel. Fentanyl patches that are leaking should not be used. No injuries have been reported in connection with the recalled lot. However, exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.

According to the company, fentanyl transdermal system CII is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.