INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box c...
FDA Recall #D-0237-2017 — Class III — December 6, 2016
Product Description
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
Reason for Recall
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Recalling Firm
Cipher Pharmaceuticals US LLC — Daniel Island, SC
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
216 boxes
Distribution
AZ, CO and OH.
Code Information
Lot #01316L02 6871201301
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated