Drug product
Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.
D-0070-2019
Product summary
- Event
- Event 80750
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7,944 tubes
- Official record key
drug-enforcement:D-0070-2019
Official wording
Reason: Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Code information: Lot: 163241K, Exp. October 2018
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent