ADDITIONAL PRODUCT:
New Recall May 24, 2007
AMO MoisturePlus contact lens solution recalled.
ROCHESTER, N.Y. March 6, 2007, – Bausch & Lomb has initiated
a limited voluntary contact lens solution recall from distribution centers and retail
shelves in the United States and specific other countries of 12
lots (over 1.5 million bottles) 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.
“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
ReNu MultiPlus Recall
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
