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Subject:
Re: Atovaquone Oral Suspension Recall
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 16 Mar 2023 12:59:15 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (464 lines) 
Don,

I am aware of the indication of this oral suspension.

I agree we do not have adequate information as to whether bacterial spores
would germinate, and grow in the product. It does contain 1% benzyl
alcohol which is most effective against Gram-positive bacteria

I believe that the clinical literature does not identify low levels of B.
subtilis in an oral dosage form as a hazard to immunosuppressed
populations. If that was the case, what foods could they consume?

Tony

On Thu, Mar 16, 2023 at 11:49 AM Donald English <
[log in to unmask]> wrote:

> Dear all,
>
> I think that some additional information is required to understand as
> to why possible Bacillus cereus contamination of Atovaquone Oral
> Suspension might be objectionable and why this product is being
> recalled.  Atovaquone Oral Suspension, USP is indicated for prevention
> and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and
> children who cannot tolerate other medicines, such as
> trimethoprim-sulfamethoxazole.  For your information, Pneumocystis
> jiroveci pneumonia is a type of pneumonia that is most likely to
> affect people with human immunodeficiency virus (HIV) and is also used
> to prevent immunocompromised patients from contracting this type of
> pneumonia.  In immunocompromised individuals, the microbial
> contamination in this type of product could lead to life-threatening
> infections such as endocarditis and necrotizing soft tissue
> infections.  In conclusion, this product is never used by individuals
> who are not immunocompromised.
>
> Don
>
> Donald J. English Microbiological Quality Consulting LLC
> Florham Park, New Jersey 07932
>
> On Wed, Mar 15, 2023 at 11:56 AM Tony Cundell <[log in to unmask]>
> wrote:
> >
> > I did publish an article on this topic.
> >
> > Cundell, T. Is *Bacillus subtilis* Objectionable in an Oral Liquid
> Solution
> > Amer. Pharm. Rev. 23 (2): 44-47 2020
> >
> > On Wed, Mar 15, 2023 at 10:12 AM Reza Garakoui <[log in to unmask]>
> > wrote:
> >
> > > Yes, I agree with you and also B.licheniformis were seen in raw
> material
> > > and many personals but there weren’t any data about this microorganism
> in
> > > USP.
> > >
> > > On Wed, Mar 15, 2023 at 02:17 Dr. Michael J. Miller <
> > > [log in to unmask]> wrote:
> > >
> > > > Contamination could have occurred from unit operations and other
> sources.
> > > > As such, B. cereus spores could remain viable in the product.
> > > >
> > > >
> > > >
> > > > The presence of B. cereus in an oral formulation is objectionable
> based
> > > on
> > > > the potential regulatory risk and uncertain risk to the patient.
> There
> > > are
> > > > no good data available on the infectious dose of this organism in the
> > > > healthy human, although cases of B. cereus pneumonia are known.
> > > >
> > > >
> > > >
> > > > FDA is concerned about Bacillus cereus as a food contaminant. The
> FDA Bad
> > > > Bug Book states that an estimated 63,400 cases of self-limiting
> diarrheal
> > > > disease occur annually. This disease is due to the production of
> > > > enterotoxin, and the FDA states “The number of organisms most often
> > > > associated with human illness is 105 to 108; however, the
> pathogenicity
> > > > arises from preformed toxin.”
> > > >
> > > >
> > > >
> > > > Gaur (2001) notes that pneumonia caused by B. cereus is possible, but
> > > > unlikely and restricted to immunocompromised patients. However,
> Bottone
> > > > (2011) presents a very different picture, discussing multiple cases
> of
> > > > infection occurring through the oral and nasal routes among healthy
> > > > individuals.
> > > >
> > > >
> > > >
> > > > Gaur, AH and JL Shenep. 2001. The Expanding Spectrum Of Diseases
> Caused
> > > By
> > > > Bacillus cereus. Ped Infect Dis J 20(5):533-534.
> > > >
> > > >
> > > >
> > > > Bottone, EJ. 2010. Bacillus cereus, a Volatile Human Pathogen. Clin
> > > > Microbiol Rev 23(2):382‐398.
> > > >
> > > >
> > > >
> > > > From: The Pharmaceutical Microbiology Forum Email List <
> > > > [log in to unmask]> on behalf of Tony Cundell <
> > > > [log in to unmask]>
> > > > Reply-To: The Pharmaceutical Microbiology Forum Email List <
> > > > [log in to unmask]>
> > > > Date: Tuesday, March 14, 2023 at 5:44 PM
> > > > To: <[log in to unmask]>
> > > > Subject: [PMFLIST] Atovaquone Oral Suspension Recall
> > > >
> > > >
> > > >
> > > > This is interesting.
> > > >
> > > >
> > > >
> > > > Camber Pharmaceuticals is voluntarily recalling lot #E220182 of
> > > Atovaquone
> > > >
> > > > Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the
> > > >
> > > > potential Bacillus cereus contamination in the product.
> > > >
> > > >
> > > >
> > > > My interest is whether B. cereus spores would survive, germinate or
> grow
> > > in
> > > >
> > > > this product that has a reduced water activity, 1% benzyl alcohol,
> and
> > > >
> > > > possibly a low pH?
> > > >
> > > >
> > > >
> > > > Based on my internet search:
> > > >
> > > >
> > > >
> > > > Atovaquone is a yellow crystalline solid that is practically
> insoluble in
> > > >
> > > > water. MEPRON oral suspension is a formulation of micro-fine
> particles of
> > > >
> > > > atovaquone.
> > > >
> > > >
> > > >
> > > > Each 5 mL of MEPRON oral suspension contains 750 mg of atovaquone
> and the
> > > >
> > > > inactive ingredients benzyl alcohol, flavor, poloxamer 188, purified
> > > water,
> > > >
> > > > saccharin sodium, and xanthan gum.
> > > >
> > > >
> > > >
> > > > *Qualitative and quantitative composition*
> > > >
> > > >
> > > >
> > > > Each ml of suspension contains 150 mg atovaquone.
> > > >
> > > >
> > > >
> > > > A unit dose of 5 ml contains 750 mg atovaquone.
> > > >
> > > >
> > > >
> > > > Excipient with known effect: Each 5 ml of oral suspension contains
> 50.00
> > > mg
> > > >
> > > > benzyl alcohol
> > > >
> > > >
> > > >
> > > >
> > > >
> > > >
> > > >
> > > > 50 mg/5 mL, i.e., 1000 mg/100 mL or 1% Benzyl Alcohol
> > > >
> > > > --
> > > >
> > > > Tony Cundell, Ph. D.
> > > >
> > > > Consulting Microbiologist
> > > >
> > > > Email: [log in to unmask]
> > > >
> > > > Cell: 914 841-0074
> > > >
> > > >
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> >
> > --
> > Tony Cundell, Ph. D.
> > Consulting Microbiologist
> > Email: [log in to unmask]
> > Phone: 914 725-3947
> > Cell: 914 841-0074
> >
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> >
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> >
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> >
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> >
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> > =================================
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>
>
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>
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>
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>
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>
>
>
> =================================
> The nature of this service is to provide a medium for communication.  The
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>


-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

------------------
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Current Sponsors:

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Novatek International https://ntint.com/

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

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



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