Drug product
Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA
D-1486-2020
Product summary
- Event
- Event 86007
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-1486-2020
Official wording
Reason: Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Code information: Lot #: 12750, Exp 5/2021
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent