Thanks Don. This is the reason I included the Gaur reference in my prior post, highlighting your points.
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Donald English <[log in to unmask]>
Reply-To: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date: Thursday, March 16, 2023 at 11:53 AM
To: <[log in to unmask]>
Subject: Re: [PMFLIST] Atovaquone Oral Suspension Recall
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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Email: [log in to unmask]
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