Lot Number 112680A, Expiration Date July 31, 2010
CORONA, CA, Mar 23, 2009 (MARKET WIRE via COMTEX) -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty
pharmaceutical company, announced today that one lot of Propafenone
HCL 225 mg Tablets sold in 100 count bottles in the United States is
being voluntarily recalled to the consumer level as a precautionary
measure. The lot is being recalled because some tablets may contain
slightly higher levels of the active ingredient than specified. The
recalled tablets were manufactured by Watson Laboratories, Inc. The
affected lot of Propafenone HCL tablets was shipped to customers
between October 15, 2008 and November 26, 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.
Propafenone is a drug product used to treat cardiac arrhythmias
(irregular heartbeats). It has a narrow therapeutic index, so some
patients who are particularly sensitive to small variations in dose
may experience potentially serious side effects, including
arrhythmias (irregular heartbeat) or low blood pressure.
Consequently, as a precautionary measure, Watson is recalling this
one lot to the consumer level to minimize any potential risk to
Anyone who has 225 mg Propafenone HCL tablets should check the bottle
for the lot number and expiration date to see if they have tablets
being recalled. Anyone with 225 mg Propafenone HCL tablets being
recalled should call (888) 352-9616, Monday through Friday, 8:00
a.m.-5:00 p.m. EDT, for instructions on how to return affected
Patients using 225 mg Propafenone HCL tablets who have medical
questions should contact their health-care provider.
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.
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 branded pharmaceuticals
focused on Urology, Gynecology and Nephrology (medical). For press
releases and other company information, visit the Watson Web site at
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; 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, 2008.
Watson Pharmaceuticals, Inc.
SOURCE: Watson Pharmaceuticals