FOR RELEASE WEDNESDAY, JANUARY 19, 2011
MADISON, N.J. -- Bausch + Lomb, the global eye health company, is conducting a voluntary recall of its Soothe® Xtra Hydration (XH) eye drops, only available within the United States.
Bausch + Lomb chose to initiate this recall based on a small number of consumer reports citing the presence of possible foreign matter in the tip of the bottles. Initial testing by Bausch + Lomb on the opened, partially-used product has identified the particles as mold.
Bausch + Lomb has chosen to voluntarily recall all existing lots of the Soothe® Xtra Hydration (XH) eye drops in the interest of patient safety. After the bottle is opened, eye drops which may become contaminated may also cause eye infections, as such the Company is taking this voluntary action to protect our consumers.
Bausch + Lomb has alerted the U.S. Food and Drug Administration of this voluntary recall.
Bausch + Lomb is currently conducting an ongoing investigation into the reports of mold in the tip of the bottles. A determination of future product distribution will be made at the close of this investigation which could last several months.
Soothe® Xtra Hydration (XH) eye drops have been available since April 2010 in the U.S. only. Approximately 1.3 million bottles have been distributed in the United States.
The voluntary recall is limited only to the United States; it does not affect locations in Europe, the Middle East or Asia-Pacific regions. The Soothe® Xtra Hydration (XH) eye drops are the only eye drops affected in this recall; all other Soothe® eye products remain on the market.
Bausch + Lomb has directly contacted U.S. retailers who have been shipped this product to initiate the recall and inform them of the steps they should take to return the product to us. The Company has also contacted eye care professionals to alert them of the recall.
The Company is asking consumers who currently have Soothe® Xtra Hydration (XH) eye drops to return the product to Bausch + Lomb. Even if consumers are comfortable using the eye drops, we urge them to return the product.
Consumers who have this product in their home should call one of the following numbers for instructions on returns and reimbursement:
Soothe® Xtra Hydration (XH) Recall Hotline: 1-877-907-9964
Bausch + Lomb customer service center: 1-800-553-5340
Bausch + Lomb’s customer service line is open to consumers 9 a.m.-5 p.m. EST Monday through Friday.
RECALLED PRODUCT DETAILS:
GC0124, GD0146, GF0121, GF0157, GJ0023, GK0044, GC0135, GC0142, GE0049, GE0050/GE0074, GF0063, GF0064/GF0065, GF0021, GG0035, GG0036, GG0055, GJ0003, GJ0004
10310119022334 (15ml size)
10310119022341 (accessory kits of 3ml size)
09/2011, 10/2011, 12/2011, 05/2012, 04/2012
03/2011, 05/2011, 06/2011, 07/2011
Packaging and Dosage:
The product is packaged in a single, sterile 0.5 FL OZ (15ml) bottle. There are 3 ml sample bottles for physicians. It is dosed as 1 to 2 drops per affected eye(s) as needed or directed by your physician.
Friday, February 4, 2011
Product recall: Soothe Xtra Hydration
Voluntary Recall of Soothe® Xtra Hydration (XH) Eye Drops