Watson has announced that one lot of 100mcg/hr Fentanyl Transdermal System patches sold in the US, is being voluntarily recalled from wholesalers and pharmacies. The recalled patches are from Lot Number: 145287A, have expiration date of February 2011, and were manufactured by Watson Laboratories and distributed by Watson Pharma.
The affected lot was shipped to customers between April 2, 2009 and May 20, 2009. 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 of the recall.
The company said that a small number of patches leaking fentanyl gel have been detected in the lot, potentially exposing patients or caregivers directly to fentanyl gel. No serious 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.