>In a message dated 98-05-08 17:09:15 EDT, you write:
>
><< Lot numbers of EpiPen and EpiPen Jr. auto-injector recalled Friday
>  by Meridian Medical Technologies.  >>
>
>I hope the FDA is going to take a good, hard look at Meridian's quality
>control program.  This is the second time in six months that Epi-Pens have
>been recalled.
>
>I was distressed to find that BOTH Epi-pens in my son's emergency kit were on
>the recall list.  Lesson learned:  make sure that Epi-pens and whatever "back-
>up" Epi-pens you have are from DIFFERENT lot numbers
>

I find it disturbing, too. The explanation that I received was that they
went to a new, automated manufacturing process, and that the EpiPens that
were filled in this way were not reliably being filled with sufficient
medication. THey have since returned to their manual filling process. I
find it surprising that a new manufacturing process was not monitored more
closely to detect problems with uniform dosages.

The previous problem was not with the quality control of the Epipen, but
with a usability design flaw in the delivery device of one type of Epipen.
This problem may not have become apparent during the testing process - it
was the possibility that the device could be triggered  without the being
in direct contact with the patient. In times of allergic crisis, confusion,
etc., it was possible to push the button and eject the dosage into the air;
unless you had an extra around, the patient could die while s/he waited for
another to be found.

While these are both quite worrisome, I do see them as different kinds of
problems, the most recent one being more disturbingly a quality control
oversight.

Until we get our EpiPens properly replaced, I will carry a couple, just in
case more epi is needed.

Mark
Mark Feblowitz                  GTE Laboratories Incorporated
[log in to unmask]              40 Sylvan Road, Waltham, MA 02154-1120