ROCHESTER, N.Y.—Bausch + Lomb said earlier this month it was
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 VM the recall has “absolutely no impact” on the
company’s sales in North America.
In a separate action, as part of its 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. “
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.”
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