/C O R R E C T I O N -- Watson Pharmaceuticals, Inc./
In the news release, "Watson Announces Limited Recall of Fentanyl
Transdermal System," issued earlier today by Watson Pharmaceuticals, Inc. over
PR Newswire, we are advised by the company that the third paragraph, third
sentence, should read "Anyone with 75 mcg/hr Fentanyl Transdermal System
patches being recalled should call 888-667-1508, Monday through Friday, 8:00
a.m.-5:00 p.m. EDT, for instructions on how to return affected product" rather
than "800-668-4391" as incorrectly transmitted by PR Newswire. Complete,
corrected release follows:
Watson Announces Limited Recall of Fentanyl Transdermal System
CORONA, Calif., Aug. 8 /PRNewswire/ -- Watson Pharmaceuticals, Inc., a
leading specialty pharmaceutical company, announced today that one lot of 75
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 92461850, have expiration dates of August 31, 2009 and
were manufactured by Watson Laboratories, Inc. The affected lot of Fentanyl
Transdermal System patches was shipped to customers between January 30, 2008
and March 19, 2008. 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 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 75 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 75 mcg/hr Fentanyl Transdermal System patches being
recalled should call 888-667-1508, 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 health-care 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 website at
http://www.fda.gov/medwatch.
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., headquartered in Corona, CA, is a leading
specialty pharmaceutical company that develops, manufactures, markets, sells
and distributes brand and generic pharmaceutical products. Watson pursues a
growth strategy combining internal product development, strategic alliances
and collaborations and synergistic acquisitions of products and businesses.
For press releases 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, including its
Fentanyl Transdermal System; risks related to our successful compliance with
extensive, costly, complex, and evolving governmental regulations and
restrictions; the difficulty of predicting the timing or outcome of FDA or
other regulatory agency approvals or actions; difficulties or delays in
manufacturing; 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 Annual Report on Form 10-K for the year ended December 31,
2007.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)
------
Watson Announces Limited Recall of Fentanyl Transdermal System
CORONA, Calif., Aug. 8 /PRNewswire/ -- Watson Pharmaceuticals, Inc., a
leading specialty pharmaceutical company, announced today that one lot of 75
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 92461850, have expiration dates of August 31, 2009 and
were manufactured by Watson Laboratories, Inc. The affected lot of Fentanyl
Transdermal System patches was shipped to customers between January 30, 2008
and March 19, 2008. 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 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 75 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 75 mcg/hr Fentanyl Transdermal System patches being
recalled should call 800-668-4391, 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 health-care 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 website at
http://www.fda.gov/medwatch.
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., headquartered in Corona, CA, is a leading
specialty pharmaceutical company that develops, manufactures, markets, sells
and distributes brand and generic pharmaceutical products. Watson pursues a
growth strategy combining internal product development, strategic alliances
and collaborations and synergistic acquisitions of products and businesses.
For press releases 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, including its
Fentanyl Transdermal System; risks related to our successful compliance with
extensive, costly, complex, and evolving governmental regulations and
restrictions; the difficulty of predicting the timing or outcome of FDA or
other regulatory agency approvals or actions; difficulties or delays in
manufacturing; 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 Annual Report on Form 10-K for the year ended December 31,
2007.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)
SOURCE Watson Pharmaceuticals, Inc.
Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-888-667-1508
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