FDA-Drug2017-01-04Class III

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

Cipher Pharmaceuticals US LLC
Hazard

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

Sold states
AZ, CO and OH.
Affected count
216 boxes
Manufactured in
115 Central Island St Ste 300, N/A, Daniel Island, SC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0237-2017

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