News
14.03.2023 - Pharmacy
Warning Letter FDA – Drugs for Children with Bacillus cereus
In January 2023, a homeopathic medicine for children was recalled by the FDA (Food and Drug Administration) due to an increased total aerobic microbial count (TAMC) and lack of approval.
The recall was initiated due to:
- Lack of approval according to the Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Microbiological contamination between 50 and 770 CFU/ml for the total aerobic microbial count (TAMC)
- Identified species: Bacillus cereus
Regularly test your products and raw materials microbiologically.
The identification of microorganisms, even if TAMC or TYMC are below the limit, is essential. Read more about this in the additional information.
The BAV Institute supports you quickly and reliably.
We look forward to your message and are happy to assist you in selecting suitable test parameters.
Sources: GMP Navigator via Link