B+L Voluntarily Recalls Certain ReNu Multi-Purpose Solution and ReNu MultiPlus Multi-Purpose Solution in Europe and Middle East
ROCHESTER, N.Y.—Bausch + Lomb said last Friday it is conducting a voluntary recall of a limited number of lots of the company's ReNu Multi-Purpose Solution and ReNu MultiPlus multi-purpose solution in Europe and the Middle East.
The first part of the recall involves a single lot (AA120) of 120ML ReNu MultiPlus multi-purpose solution in Croatia, Dubai, Hungary, Slovenia, Romania, Turkey and Saudi Arabia. The company said the recall is being initiated as a precaution as a small number of sensitivity issues with lot AA120 120ML ReNu MultiPlus multi-purpose solution have been reported. "To put this in context," a statement said, "the number of reports represents less than 0.1 percent of the packs within this lot. However, as a precaution, Bausch + Lomb has taken the decision to initiate a voluntarily recall of this product. We have directly contacted retailers and eyecare professionals who have been shipped this product to initiate the recall and inform them of the steps they should take to return product to us."
Describing the move as "voluntary and precautionary," a B+L spokesperson told VMail the recall has "absolutely no impact" on the company's sales in North America.
In a separate action, as part of our ongoing commitment to quality assurance, Bausch + Lomb is also voluntarily recalling a limited number of lots of its ReNu Multi-Purpose Solution and ReNu MultiPlus multi-purpose solution in Europe and the Middle East.
"Routine testing has shown that while these products are safe and effective when used as directed, they are not meeting our quality expectations," a statement said, adding, "We decided to initiate the quality-related recall after our Stability Monitoring Program showed that the performance trend of certain lots did not meet our expectations. There is no indication of a safety or efficacy issue and there have been no reported adverse events; rather, this recall is being conducted as a precaution. Our Stability Monitoring Program is designed to identify potential problems months before they occur and is part of our drive to provide best-in-class manufacturing and quality processes. We remain steadfast in our commitment to delivering vision care products that meet the highest quality standards. We have notified retailers and eyecare professionals about the steps they should take if they have product from the affected lots in their inventories."
The company stated, "No other Bausch + Lomb products, including other lots of ReNu Multi-Purpose Solution and ReNu MultiPlus multi-purpose solution, are affected by this action."