Proheart®
6 recall.
People have asked me what does this
mean.
First, this is only a partial recall......
for the product manufactured in June '03 and distributed
from July '03 to Jan '04. There are only two lot numbers:
"Lot 367158214, Exp. April 05, and Lot
367158215, Exp. June 05" and only made
in 5 packs not the 10 packs.
The reason for it? It failed six month
'stability tests.' According to the recall letter: "the
dissolution results that were out of specification during
routine six month stability testing." The FDA Enforcement
Report clarifies that the microspheres (which are time
released') were not breaking down the way they were
suppose to six months after being manufactured.
The manufacturer started the recall
on 4/27/04. It took the FDA till 6/9/04 to grade the
seriousness of it. It was Class II (in the middle),
"may cause temporary or medically reversible adverse
health consequences or where the probability of serious
adverse health consequences is remote."
Questions that I don't have answers to:
1. Does that mean a dog could become heartworm positive
on a bad dose?
2. Does that mean the microspheres stay at the injection
site?
3. Should extra precautions be taken?
4. Will there be long term problems from it not dissolving?
5. Where do I find these answers?
If your companion received this
drug between July '03 and Jan '04, I would suggest you
contact your vet and see if he had/has either of these
lot numbers, if your dog received it. If this is affirmative
then ask him the answers to the above and any others
that you may have.
The vets were also given a choice of
having the product replaced....... or to be given a
credit for it.
How often are 'stability' tests run?
another good question.
~~~~~~~~~~~~~~~~~~
Warning
Letter of 3/31/04, what does this mean?
In summary, FDA did a plant manufacturing
inspection at a Fort Dodge location December 1-12, 2003.
" This inspection revealed serious deviations from
the current Good Manufacturing Practice (cGMP) regulations."
Of the six items listed in this letter
issued almost 4 months later, concerned sterile processes,
including #5 that the heat exchanger "used in the
Small Volume Parenteral manufacturing rooms" -
"was found to be contaminating the water for injection
(WFI) with bacteria. The failure investigation did not
extend to reviewing the possible impact on other previously
manufactured drug products. In addition, the heat exchanger
continued to be used to manufacture other parenteral
products after the equipment was identified as being
contaminated."
When will they be inspected again? I don't
know. Has any response been posted yet? No. Does this
mean that the six month injection has been contaminated
with bacteria? Good question. How long had this been
going on to involve how many lots? Don't know.
Could this be why we see so many different
types of reactions?
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