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Watson recalls fentanyl patches in US

This article was originally published in Scrip

Executive Summary

Watson Pharmaceuticalsis recalling one lot of fentanyl transdermal system patches in the US because of the potential for leakage. The 75μg/hr patches were shipped between January 30th and March 19th. Patches leaking fentanyl gel have been detected, potentially directly exposing patients and caregivers to the active ingredient. No injuries have been reported, but exposure to fentanyl gel may lead to respiratory depression, overdose and death. Leaks have proved to be a problem for several companies marketing fentanyl patches. Earlier this year Actavis recalled all fentanyl patches sold in the US owing to a possible fold-over defect that could cause leakage. Johnson & Johnson recalled all lots of 25μg/hour Duragesic patches and 25μg/hour fentanyl patches sold by Novartis's Sandoz unit because the products may have a cut along one side, which could result in leakage. Recalls also were initiated by J&J and Ranbaxy Laboratories in Canada.

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