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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Current Sponsors:

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

Novatek International https://ntint.com/

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

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



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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 PMF or the sponsors of the list.