D-0237-2017 Class III Ongoing
FDA drug recall D-0237-2017 was initiated by Cipher Pharmaceuticals US LLC on December 6, 2016 and is designated Class III. Reason for recall: Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications. The recall status is ongoing. Affected quantity: 216 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- January 4, 2017
- Initiation Date
- December 6, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216 boxes
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.
Distribution Pattern
AZ, CO and OH.
Code Information
Lot #01316L02 6871201301