PMFLIST Archives

October 2019

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 11 Oct 2019 23:32:41 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (143 lines)
Dear Abby,

In all probability, the source of the Burkholderia cepacia complex
contamination in this recalled product formulation is from the water supply
that had been used to formulate the product.
In looking at the composition of this recalled aqueous product formulation,
Methylchloroisothiazolinone and Methylisothiozolinone , a mixture that is
otherwise known as Kathon CG, is being used as the preservative system.  It
should also be noted that the company had misspelled
Methylchloroisothiazolinone on the recall product label.

Kathon CG has good antimicrobial activity against Burkholderia cepacia
complex.  However, this recalled formulation contains Triethanolamine.  I
wonder whether there is also a preservation issue with this formulation.
In general, amines and amine derivatives have been shown to have a
deleterious effect on the chemical stability of Kathon CG in product
formulations.  If the pH of the formulation had not been adjusted to be
lower than 7.0, the amines in the formulation would not have been converted
to the acid form which would not have an adverse effect on the chemical
stability of this preservative system.

Generally, Kathon CG should only be used in rinse-off product
formulations.  By reading usage directions for this recalled product
formulation, it states to apply the product directly to the electrode site,
rub gently and wipe down. This product usage directions does not look like
a rinse-off product formulation  because water is not used to rinse the
formulation away from the skin.  In the EU and Canada, Kathon CG can only
be used in rinse-off product formulations.

Besides the product being recalled due to the presence of Burkholderia
cepacia complex contamination and misspelling of
Methylchloroisothiiazolinone on the product label, I suspect that there is
more to this recall.

Regards,
Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932

On Mon, Sep 30, 2019 at 6:06 PM Abby Tripp <[log in to unmask]> wrote:

> The FDA recently posted a recall by Mavidon due to Burkholderia cepacia
> contamination- I thought it was relevant due to the recent threads about B.
> cepacia testing:
>
>
>
> Mavidon Issues Voluntary Worldwide Recall of LemonPrep Tubes and Single Use
> Cups
> <
> https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mavidon
>
> -issues-voluntary-worldwide-recall-lemonprepr-tubes-and-single-use-cups?utm_
>
> campaign=FDA%20MedWatch%20-%20LemonPrep%20Tubes%20and%20Single%20Use%20Cups%
> 20by%20Mavidon&utm_medium=email&utm_source=Eloqua
> <https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mavidon-issues-voluntary-worldwide-recall-lemonprepr-tubes-and-single-use-cups?utm_campaign=FDA%20MedWatch%20-%20LemonPrep%20Tubes%20and%20Single%20Use%20Cups%20by%20Mavidon&utm_medium=email&utm_source=Eloqua>>
>
>
>
>
> We hope to have the required media will be readily available by the time
> Dec. 1st rolls around.
>
>
>
> Abby Tripp
>
> Director of Quality
> Northeast Laboratory Services
>
>
>
>
>
>
> ------------------
> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
> The Microbiology Network (http://microbiologynetwork.com) and supported by
> our sponsors as a service to the scientific community.
>
> Please take a second to visit our sponsors' web sites and say thank you
> for their support of this service.
> If your company would be interested in sponsoring this community, please
> contact [log in to unmask]
>
>
>
> Science Advisory Board https://www.scienceboard.net/
>
> Steris - http://www.sterislifesciences.com/
>
> Charles River Laboratories - http://www.criver.com/
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> BD Industrial Media - http://www.bd.com/ds/
>
> Boston Analytical http://www.bostonanalytical.com/
>
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
>
> =================================
> The nature of this service is to provide a medium for communication.  The
> specific statements and endorsements of individuals participating in the
> discussions are not necessarily those of The Microbiology Network, Inc.,
> the PMF, or the sponsors of the list.
>

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

Steris - http://www.sterislifesciences.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

ATOM RSS1 RSS2