U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Sun, 2 Mar 2008 17:05:04 -0600 (CST)
Subject: Actavis Recalls Remaining Fentanyl Patches in the US as Precaution (Mar. 1)

Actavis Recalls Remaining Fentanyl Patches in the US as Precaution (Mar. 1)
Sun, 2 Mar 2008 15:21:00 -0600

This recall is an expansion of the Company's initial recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008. That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the fentanyl gel. The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects.

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