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, the U.S. Food and Drug Administration (FDA) just announced.
Bausch + Lomb initiated this recall based on some reports predominantly within a specific age group—age 70 and older—who reported difficulty swallowing or who experienced a choking sensation when taking the soft gel.
The lot numbers involved include: 0923BK103, 0924BK103, 0924BK103A, 0925BK103A, 0926BK103A, 0927BK103A, 0928BK103A, 0929BK103A, 0930BK103A. The UPC Code is 24208 62584 and the expiration date is 08/31/2011. 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.
The voluntary recall is limited only to the United States and does not affect locations in Europe, the Middle East, or in 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.
The formulation of PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 is safe, according to Bausch + Lomb, which noted that many of its customers can comfortably swallow the supplement; however, it does believe the design of the soft gel requires further consideration.
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.
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 Bausch + Lomb. Bausch + Lomb has also contacted eye care professionals to alert them of the recall.
Bausch + Lomb is also 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, they are urged to return the product. Consumers with this product in their home should call Bausch + Lomb’s customer service center for instructions on returning and reimbursement at 1-800-553-5340. Bausch + Lomb’s customer service line is open to consumers 9:00 am-5:00 pm Eastern Standard Time, Monday through Friday.
