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.
Westone Laboratories Inc. Issues Voluntary Nationwide Recall of all sizes and packaging configurations of Oto-Ease® ear lubricant due to possible microbial contamination.
Contact
Consumer
1-800-357-3240
FOR IMMEDIATE RELEASE – July 13,2012, Westone Laboratories, Inc. is initiating a voluntary nationwide recall of all sizes and packaging configurations of Oto-Ease® ear lubricant. The products have been found through a consumer complaint and the U.S. Food and Drug Administration (FDA) sample analysis to be potentially contaminated with pathogenic bacteria and mold. Use of the product as directed for easing the insertion of custom fit ear molds and hearing instruments (including hearing aids) could result in infectious complications of the ear canal and surrounding tissues.
This product was previously recalled in October 2011 within the United States and from Australia (without FDA knowledge).
Consumers who have any size or packaging configuration should stop using the product and contact their healthcare provider. Packaging configurations include the following:
1) 0.5 oz semi transparent flexible plastic bottles with orange or semi transparent plastic screw-on dispensing caps; and
2) aluminum foil single use sample packs with red or black print writing.
The Oto-Ease unit containers are not identified with a lot number, expiration date, or UPC Code.
No injuries or illnesses have been reported to date. This recall is being conducted with the full knowledge of the FDA.
Westone Laboratories is notifying its distributors and customers through direct letter and issuance of this news release and is arranging for the disposal or return of all recalled products.1-800-357-3240 between the hours of 8:00am and 5:00pm MST or email
The products were distributed to hospitals, health professionals, and retailers nationwide and to Belgium, Greece, Canada, Thailand, Australia, Panama, Singapore, Russian Federation, Ireland, The Philippines, France, Korea, United Kingdom, Switzerland, Brazil, Japan, Germany, Mexico, Hong Kong, Sweden.
Consumers with questions may contact Westone Laboratories at at otoeaserecall@westone.com.
Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Events Program either online, by regular mail or by fax.
Online: www.fda.gov/medwatch/report.htm1
Regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm2
Fax: 1-800-FDA-0178
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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.
Voluntary Recall of Purina® Products Due to Potential Elevated Vitamin D Level
Contact:
Media
Trish Scorpio, Land O’Lakes Purina Feed
651-375-1814
Consumer
(1-800-522-3354)
FOR IMMEDIATE RELEASE – July 13, 2012 –Land O’Lakes Purina Feed LLC has initiated a voluntary recall of specific lots of Purina® feed products listed below, due to the potential for elevated vitamin D levels. Elevated vitamin D levels may cause death or otherwise be harmful to animals and fish if fed for extended periods, potentially resulting in lack of interest in eating, weight loss and possible joint stiffness.
Although no customer complaints have been received to date, the following products with specific lot numbers are being recalled as a precaution, due to analytical test results on retained samples that indicate a potential for elevated levels of vitamin D.
The products were manufactured at the Richmond, IN feed plant and were distributed nationwide starting April 2, 2012 through May 8, 2012. Dealers have been contacted and asked to hold these products and to notify and retrieve the product from customers. The affected product should not be used, and where applicable, be returned to the retail dealer.
Formula No. Item No. Description Lot Numbers
Lot numbers for the WellSolve W/G® product are laser printed at the bottom of the label next to the ingredients listing on each bucket. Lot numbers for the other recalled products are laser printed on the back of each paper bag near the top. Lot numbers are formatted as follows: APR= Month / 17=Day of Month / 12 =Year / 2 =Plant Code.
Customers should return remaining products to their local dealer to receive a refund. For more information on the product recall, contact your local dealer or Customer Service (1-800-522-3354) between the hours of 8:00 a.m. and 4:00 p.m. (EDT), Monday through Friday.
REPOST – Courtesy of FDA
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