Biomed Laboratories, Llc.: Tychasis Coats Aloe Lotion (allantoin 0.5%)
- Recalling firm
- BioMed Laboratories, LLC.
- Product
- Tychasis Coats Aloe Lotion (Allantoin 0.5%) packaged in a)0.5 oz, b)8 oz (NDC 70211-704-08), and c)33 oz (NDC 70211-704-33) bottles, Manufactured for: Tychasis Corporation, Dallas, TX 75227. There is no NDC for the 0.5 oz given that it is a sample size used as a professional sample.
- Reason
- Failed Stability Specifications: OOS stability results included viscosity and appearance results that did not align with the established specifications.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-10-15
- Status
- Ongoing
- Areas affected
- TX
- Distribution
- TX only
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/1946a36b-e314-4cb5-ba82-e93269afeca3