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Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Watson Announces Important Action Related to Nationwide Recall of Triad Alcohol Prep Products Included in Products
Watson Pharmaceuticals, Inc.
FOR IMMEDIATE RELEASE - February 4, 2011 -Watson Pharmaceuticals, Inc. (NYSE: WPI), announced today the market recall of alcohol prep pads manufactured by Triad Group which is a component of a convenience kit that is distributed with its products. Triad Group is recalling the alcohol prep pads packaged with products, including Watson’s Trelstar® (triptorelin pamoate for injectable suspension) product, due to potential contamination of the pads with the bacteria, Bacillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.
The Company emphasized that there is no potential contamination of the Trelstar product, the MIXJECT® system or components in the Trelstar packaging, other than the Triad alcohol prep pad. The Trelstar drug and the MIXJECT® system have not been affected in any way.
Watson has ceased shipments of Trelstar packaging components that incorporate the Triad alcohol pad while it pursues options to remove or replace the prep pad. Convenience kits will not be available in Trelstar commercial packages until new convenience kits incorporating a replacement alcohol prep pad are available for distribution in March 2011. The Company also noted that it was cooperating fully with the FDA, and notifying its customers.
Watson instructs customers to immediately discontinue the use of the Triad alcohol prep pad included in the Trelstar convenience kit and to appropriately dispose of the entire convenience kit. The Company also recommends customers use an alternative alcohol prep pad product that is not involved with this recall, or to use a sterile gauze pad in conjunction with isopropyl alcohol as an alternative. Both prep pads and gauze should be available at your local pharmacy.
Further information on this Triad alcohol prep pad recall can be found on the FDA website at
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Regular Mail: use postage-paid, pre-addressed Form FDA
3500 available at:www.fda.gov/MedWatch/getforms.htm
Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health. Watson has operations in many of the world's established and growing international markets. Trademarks are property of their respective owners.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. 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; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson, its subsidiaries, and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such 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, 2009 and Watson's quarterly report on Form 10-Q for the period ended September 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.