PlainRecalls
FDA Drug Low Class III Ongoing

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

Reported: January 4, 2017 Initiated: December 6, 2016 #D-0237-2017

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.

Details

Units Affected
216 boxes
Distribution
AZ, CO and OH.
Location
Daniel Island, SC

Frequently Asked Questions

What product 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. Recalled by Cipher Pharmaceuticals US LLC. Units affected: 216 boxes.
Why was this product recalled?
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 4, 2017. Severity: Low. Recall number: D-0237-2017.