Other safety alerts
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| The United States: FDA warns nine manufacturers and distributors of unapproved antimicrobials for animals |
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The US Food and Drug Administration (FDA) announces the issuance of nine warning letters to manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs for violations of federal law. The agency is concerned because these products contain antimicrobials that are important in human medicine and using them without medical oversight contributes to the development of antimicrobial resistance. Antimicrobial resistance happens when microorganisms like bacteria become resistant to the antimicrobials that are designed to kill them.
The marketed products are not the subject of the main legal pathways for animal drugs to reach the marketplace. Therefore, the FDA has not verified their safety or effectiveness as part of the animal drug review process or facility inspections.
The animal products referenced in the warning letters are marketed and labeled for minor species such as aquarium fish and pet birds. They contain antimicrobials that are important in human medicine, such as amoxicillin, penicillin, tetracycline, and erythromycin, and are being illegally marketed over the counter. Anyone currently using or administering the products included in these warning letters should safely dispose of them. For details of the affected products, please refer to the website in FDA.
The following companies received warning letters:
- American Aquarium Products
- Aquanest Biotic
- Aquarium Pharmacy LLC
- California Veterinary Supply
- Chewy Inc.
- Kraft Drug
- Midland Veterinary Services LLC
- Silver Lease LLC
- Valley Veterinary Clinic LTD
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/fda-warns-nine-manufacturers-distributors-unapproved-antimicrobials-animals
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by the above nine companies.
Ends/Friday, Dec 15, 2023
Issued at HKT 15:30
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