FDA recall D-0237-2017

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

Reason for recall

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

Distribution

AZ, CO and OH.

Key facts

Status

Ongoing

Initiation date

2016-12-06

Report date

2017-01-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Daniel Island, SC, United States

Primary source

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