Drug product
INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01
D-0237-2017
Product summary
- Event
- Event 76011
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 216 boxes
- Official record key
drug-enforcement:D-0237-2017
Official wording
Reason: Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Code information: Lot #01316L02 6871201301
Distribution pattern: AZ, CO and OH.
Derived failure modes
-
Potency or specification failure
Subpotent