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Press Release
| Watson Announces Limited Recall Of Fentanyl Transdermal System |
MORRISTOWN, N.J., 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, 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 For press release and other company information, visit 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
(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)
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