Cipher Pharmaceuticals US LLC recalls INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of b…

Recall date

December 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0237-2017

FDA classification

Class III

Brand / firm

Cipher Pharmaceuticals US LLC

Sold / distributed

AZ, CO and OH.

Why it was recalled

Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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