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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 Soothe® Xtra Protection (XP) Eye Drops
Elizabeth Harness Murphy
FOR IMMEDIATE RELEASE - February 24, 2011 - Bausch + Lomb, the global eye health company, is conducting a voluntary recall of its Soothe® Xtra Protection (XP) eye drops. Soothe XP is only available within the United States. (Expiration Dates: February 2011 through August 2012)
Bausch + Lomb chose to initiate this recall based on testing which showed specific lots of the Soothe Xtra Protection (XP) product were out of specification for preservative efficacy prior to their listed date of shelf-life expiration. There have been no adverse events reported for this product which have been attributed to preservative efficacy.
Bausch + Lomb has chosen to voluntarily recall ALL LOTS of Soothe Xtra Protection (XP) eye drops in the interest of patient safety. Product which is out of specification near the end of shelf-life may present insufficient protection against inadvertent microbial contamination during storage and usage of the product. Potential adverse events may include: burning, stinging, eye redness or eye discomfort. Please contact your doctor if you have any of these symptoms.
Bausch + Lomb has alerted the U.S. Food and Drug Administration of this voluntary recall.
The company is conducting an ongoing investigation to determine why these specific lots of Soothe Xtra Protection (XP) eye drops were out of shelf-life specification.
Soothe Xtra Protection (XP) eye drops have been available since August 2007 in the U.S. only.
Only Soothe Xtra Protection (XP) eye drops are affected by this recall; To Clarify, Soothe Preservative Free eye drops and Soothe Night Time Ointment continue to be available to consumers.
Bausch + Lomb has directly contacted U.S. retailers who have been shipped 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 Protection (XP) eye drops not to use the product and return it to Bausch + Lomb. Even if consumers feel comfortable using the eye drops, they should stop using the product and return it to Bausch + Lomb.
Consumers who have this product in their homes should call one of the following numbers for instructions on returns and reimbursement:
Soothe Xtra Protection (XP) Hotline: 1-866-761-9526
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
Packaging and Dosage:
The product is packaged in a single, sterile 15ml bottle and a single, sterile 2.5 ml sample size for use by physicians. It is dosed as one to two drops in the affected eye(s) as needed or directed by your doctor.
15 ml Product Information:
Lot Numbers (15 ml bottle):
397291, 397381, 397561,397711, 397731, 397921, 397931, 407051, 407611, 407631, 417061, 427131, 437271, 437501, 437521, 447181, 447191, 448061, 448071, 457001, 457171, 457191, 457881, 458001, 467201, 477101, 477111, 477911, 487311, 487571, 497111, 497561, 507741, 507861, 517131, 517911, 518021, 537001, 537131, 537141, 537391, 537661, 537671, 537921, 538051, 547011, 547201, 547221, 547231, 547631, 547651, 548171, 557021, 557032, 557451, 130241, 130541, 130831, 130841, 131381, 131391, 132081
Expiration Dates (15 ml bottle):
02/2011, 03/2011, 04/2011, 05/2011, 06/2011, 07/2011, 08/2011, 09/2011, 10/2011,11/2011, 12/2011, 01/2012, 02/2012, 04/2012, 05/2012, 06/2012, 07/2012, 08/2012
2.5 ml Sample Size Product
Lot Numbers (2.5 ml sample size):
487531, 497311, 497321,507311,507531, 507541, 517971,517981, 537101, 537331, 537651, 547241, 557351, 557462, 131341, 132251, 133341, 133821
Expiration Dates (2.5 ml sample size):
2/28/2011, 3/31/2011, 4/30/2011, 5/31/2011, 7/31/2011, 8/31/2011, 9/30/2011, 10/31/2011,
Please note that Soothe Xtra Protection (XP) has undergone a packaging change in recent months. Below are images of both types of product packaging being voluntarily recalled.
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 one of the best-known and most respected healthcare companies in the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. 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.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.