FDA Alert: Bausch & Lomb Recall of 12 Lots of ReNu MultiPlus Solutions
FOR IMMEDIATE RELEASE -- Rochester, New York -- March 6, 2007 -- Bausch &
Lomb (NYSE/BOL) has initiated a limited voluntary recall from distribution
centers and retail shelves in the United States and specific other countries of
12 lots of ReNu MultiPlus lens care solution made at its plant in Greenville, SC
because they contain an elevated level of trace iron. This may result in
discoloration of the solution in some bottles, and the shelf life of the product
may be shortened to less than its two-year expiration date, due to a potential
loss of effectiveness over time. The Company has received no reports of serious
adverse events associated with these lots and believes virtually all of the
affected product, manufactured about a year ago, has already been used by
consumers. Bausch & Lomb has notified the U.S. Food and Drug Administration
of this voluntary action.
About a million bottles of solution from nine
of the 12 lots were originally distributed in the United States. Product from
the 12 affected lots was also distributed in Canada, Latin America, Korea and
Taiwan, where it is also being recalled.
The company initiated an
investigation after receiving three customer reports of discolored solution. The
root cause of the discoloration was determined to be an elevated level of trace
iron in a single batch of raw material sourced from an outside supplier. Iron is
an element present at trace levels – measured in parts per billion – in many
compounds used in manufacturing food, drug, medical device and cosmetic products
for human use. The elevated level of trace iron could combine with other
compounds in the solution to cause discoloration which signals that the solution
may be losing effectiveness over time.
"We have always maintained that
the health and safety of consumers is our top priority," said Angela J.
Panzarella, vice president and head of Bausch & Lomb's global vision care
business. "With detailed and specific information about the distribution of the
affected product, and good information about consumer use patterns, we are
highly confident that virtually all of the affected product was used before it
began to lose effectiveness. We're now in the process of confirming with
distributors and retailers that there is no product still available for sale
anywhere."
"We are confident we have identified the source of the
problem and we are taking appropriate measures designed to avoid a recurrence,"
Panzarella said.
Bausch & Lomb does not expect the costs associated
with this limited recall will have a significant impact on its financial
results.
If consumers notice that their lens care solution appears to be
discolored, they should discard it, as it may be losing effectiveness. The
recalled lots all carry the expiration date "2008 – 03" on the bottle. Consumers
who have bottles from the lot numbers listed below should check the Company's
web site at www.bausch.com/productrecall or call the consumer affairs line
(1-866-259-8255) to arrange for a replacement.
LOT NUMBERS SUBJECT TO
RECALL: GC6030 – GC6037 – GC6038 – GC6045 – GC6048 – GC6052 – GC6061 – GC6063 –
GC6072 – GC6073 – GC6080 – GC6085
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