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[IP] [misc.health.diabetes] Trouble with stoppers on Humalog vials

I thought that this post might be of interest to many of us. I have not
noticed any problems with Humalog spraying, but I don't inject air into the
vial and of course I use the pump reservoir needle, not a syringe.
I don't have any more information than is in the post. 

email @ redacted

------- Start of forwarded message -------
From: email @ redacted (DKC)
Newsgroups: misc.health.diabetes
Subject: Trouble with stoppers on Humalog vials
Date: Sat, 18 Apr 1998 16:29:52 GMT
Organization: Los Angeles Free-Net
Message-ID: <email @ redacted>

Last month I brought to Eli Lilly's attention that the rubber stoppers
on vials of Humalog (Lispro) seemed much less supple than on other types
of insulin, with the result that the syringe needle is easily blunted.
Lilly immediately replaced the vials with Penfill cartridges (no charge,
via my local pharmacy) and sent a pre-paid mailer to forward the vials
to them.  They have now sent the following letter, confirming that there
IS a problem with the stoppers -- in fact more than one:


  						        Eli Lilly and Company
							   Lilly Corporate Center
							 Indianapolis, Indiana 46285
								317 . 276 . 2000

     April 15, 1998

     Dear Mr. Cohler:

	This letter is in response to difficulty experienced with VL7510
Humalog.  The complaint stated that the Humalog stoppers are difficult
to puncture.

	Eli Lilly and Company is very concerned about manufacturing
products that meet every patient's expectations.  We regret any
difficulty you may have experienced.  The product you returned was
forwarded to our area for a technical evaluation.  In discussions with
Technical Services, it was determined that the stoppers for Humalog are
manufactured from a material that is less resilient than the material
used for some other insulin stoppers.  As a result, these stoppers are
more difficult to puncture and may also leak or "spray back" on
occasion.  When the needle is withdrawn, the needle cut in the stopper
may close more slowly, emitting a fine spray.  Our Technical Services
area is currently looking at potential options to address these issues.
Meanwhile, these conditions may be reduced by letting the vial warm to
room temperature just prior to use.  This will improve the stopper
resiliency.  In addition, it is recommended to avoid over-pressurization
of the vial.  If excessive air is introduced into the vial over multiple
doses, the vial can become over-pressurized, which can increase the
possibility of "spray back".

	We apologize for any inconvenience that this may have caused you
and we appreciate your taking the time to notify us of this occurrence.
Feel free to contact us whenever you have a question concerning a Lilly



     Linda S. Boothe, R.Ph.
     Consumer Technical Service
     CID (40512)


David Cohler, South Pasadena, CA
Media Access Consultancy
[To reply by e-mail, delete "removeme." -- including the extra "."]

------- End of forwarded message -------
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