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
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.
Bausch + Lomb chose to initiate this voluntary recall because the
Company feels it is in the best interest of our patients to make certain
they have a high-quality product which meets their eye health needs.
News Media Contacts:
Elizabeth Harness Murphy
Manager, Corporate Communications and Public Affairs, Bausch + Lomb
+1 585-281-8219 (mobile) or Elizabeth.Murphy@bausch.com
About Bausch + Lomb
Bausch + Lomb is dedicated to bringing visionary ideas to eye health.
Its core businesses include contact lenses and lens care products,
ophthalmic surgical devices and instruments, and ophthalmic
pharmaceuticals. The Bausch + Lomb name is one of the best-known and
most respected healthcare brands in the world. Founded in 1853, the
company is headquartered in Rochester, N.Y., and employs more than
10,000 people worldwide. Its products are available in more than 100
countries. More information is available at www.bausch.com.