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INGfertility
Safety Assurance |
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In Jan
2009, FDA posted a delayed
recall notice regarding
Pre'®
Lubricant in individual
vials, based on
INGfertility's voluntary
market withdrawal of this
product. However, all
product had already been
removed from the market by
the time of the posting.
INGfertility contacted the
FDA in Jan 2009 to confirm
that the product was not
"out of specification" and
that INGfertility's action
did not constitute a recall
(which are manufacturer
originated).
Pre'®
Lubricant, Lot 5213 is
not and was not out of
specification. There is not,
and has never been, any
public safety or consumer
issues associated with this
product. In September of
2008, results of ongoing
routine testing of a lot of
Pre'®
produced results that may
have made the product be
"out of specification,"
which means that it may not
meet the standards set by
INGfertility. INGfertility,
in an abundance of
caution immediately
contacted anyone who had
received this product to
have the product removed
from the market during
re-testing. INGfertility
voluntarily contacted the
FDA regarding the
withdrawal. Subsequent
testing found that the
product was, in fact, within
specifications. The product
had already begun to be
returned to INGfertility and
was out of commerce in
October 2008, when final
confirmatory test results
became available. Again,
those confirmatory results
demonstrated that the
product was safe and not out
of specification.
More Information About the Compa
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Pre-Seed and Pre Lubricant
Read What Healthcare Providers are Saying!
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"We
recommend Pre-Seed®
to our patients who are trying to conceive. We have found it to be
of excellent viscosity… It is not sticky (as are some lubricants).
We most certainly endorse this product." Drs. Katz & Tabisel,
Women's Therapy Center, Plainview, NY |
Letter from Dr.
E!
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