MORRISTOWN, N.J., Aug. 7 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI - News), a leading specialty pharmaceutical company, announced today that one lot of 100 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies. The recalled patches are from Lot Number 145287A, have expiration dates of February 2011 and were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc. The affected lot of Fentanyl Transdermal System patches 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 U.S. Food and Drug Administration (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 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.
Anyone who has 100 mcg/hr Fentanyl Transdermal System patches should check the box or foil pouch for the lot number and expiration date to see if they have patches that are being recalled. Affected patches should not be handled directly. Anyone with 100 mcg/hr Fentanyl Transdermal System patches being recalled should call 888-345-2656, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for instructions on how to return affected product.
Patients using fentanyl patches who have medical questions should contact their healthcare providers.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
Watson’s 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.
Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of brand pharmaceuticals focused on Urology, Women’s Health and Nephrology/Medical.
For press release and other company information, visit Watson Pharmaceuticals’ Web site at http://www.watson.com.
Forward-Looking Statement
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson’s current expectations depending upon a number of factors affecting Watson’s business. These factors include, among others, the impact of competitive products and pricing; market acceptance of and continued demand for Watson’s products; difficulties or delays in manufacturing; the difficulty of predicting the timing or outcome of FDA or other regulatory agency approvals or actions, if any; and other risks and uncertainties detailed in Watson’s periodic public filings with the Securities and Exchange Commission, including but not limited to Watson’s Quarterly Report on Form 10-Q for the period ended June 30, 2009.
