Trifecta Pharmaceuticals Recalls Clotrimazole Cream Over cGMP Issues
Trifecta Pharmaceuticals recalled 14,700 bottles of Globe Clotrimazole Cream USP on October 31, 2025, due to significant cGMP deviations. The affected product may not meet necessary safety and quality standards. Consumers should stop using the cream immediately and seek guidance from healthcare providers.
About This Product
Globe Clotrimazole Cream USP, 1% is an antifungal cream commonly used to treat skin infections such as athlete's foot and jock itch. Consumers buy it for its effectiveness in combating fungal infections.
Why This Is Dangerous
cGMP deviations can lead to manufacturing processes that fail to ensure the safety, quality, or efficacy of the product. This can result in a product that may not perform as expected or could pose health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall requires consumers to stop using the product and consult healthcare providers, potentially causing inconvenience and concern about health safety.
Practical Guidance
How to identify if yours is affected
- Check the packaging for the lot number A472418.
- Verify if you purchased the product after January 2025.
- Look for the product weight of 5 oz. (142 g) on the tube.
Where to find product info
The lot number is typically printed on the bottom of the tube or on the packaging.
What timeline to expect
Expect to receive guidance and notification via letter within a few weeks.
If the manufacturer is unresponsive
- Document all communication attempts with Trifecta Pharmaceuticals.
- Reach out to the FDA for further assistance if necessary.
- Consider filing a complaint with consumer protection agencies.
How to prevent similar issues
- Look for FDA approval or certification when purchasing medications.
- Check for clear labeling on manufacturing standards.
- Be cautious of products with vague descriptions or lack of safety information.
Documentation advice
Keep a record of your purchase receipt, any correspondence regarding the recall, and photographs of the product.