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U.S. Department of Health and Human Services

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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 PreserVision® Eye Vitamin AREDS 2 Formula in the United States

 

Contacts:

Laurie WoodingElizabeth Harness Murphy
Global Pharma Communications, Bausch + LombManager, Corporate Communications and Public Affairs, Bausch + Lomb
+1- 862-222-7312 (mobile) or Laurie.Wooding@bausch.com+1 585-281-8219 (mobile) or Elizabeth.Murphy@bausch.com

 

FOR IMMEDIATE RELEASE -- MADISON, N.J. - Bausch + Lomb is conducting a voluntary recall of its PreserVision® Eye Vitamin AREDS 2 Formula with Omega 3 soft gels, only available within the United States.

Bausch + Lomb chose to initiate this recall based on a small number of reports predominantly within a specific age group, age 70 and older, who reported difficulty swallowing or a choking sensation when taking the soft gel.

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 PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 is the only supplement affected in the recall; all other PreserVision and Ocuvite® supplements, soft gels and tablets, remain on the market.

To clarify, the formulation of PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 is safe. While many of our customers can comfortably swallow the supplement, we believe the design of the soft gel requires further consideration. Our customers are our top priority, and we want to ensure they have a supplement which is comfortable to use on a daily basis.

Bausch + Lomb expects to release an AREDS 2 formulation in a smaller soft gel which will be dosed twice per day, two pills per dose. This immediate redesign is expected to be available to customers by later this year.

We have 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. We have also contacted eye care professionals to alert them of the recall.

We are asking consumers who currently have the PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 to return the product to Bausch + Lomb. Even if consumers are comfortable swallowing the soft gel, we urge them to return the product.

Consumers who have this product in their home should call our customer service center for instructions on returning and reimbursement: 1-800-553-5340. Bausch + Lomb’s customer service line is open to consumers 9am-5pm EST Monday through Friday.

AFFECTED PRODUCT DETAILS:

Lot Numbers:
0923BK103, 0924BK103, 0924BK103A, 0925BK103A, 0926BK103A, 0927BK103A, 0928BK103A, 0929BK103A, 0930BK103A

UPC Code: 24208 62584

Expiration Date: 08/31/2011

Packaging and Dosage:
PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 soft gels are packaged in 60 count bottles. The current dosage for the AREDS 2 formulation is two soft gels per day.

Bausch + Lomb chose to initiate this voluntary recall because we feel it is in the best interest of our patients to make certain they have a high-quality product which is comfortable to use on a daily basis.

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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.

® and ™ denote trademarks of Bausch + Lomb Incorporated

 

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