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
This recall is currently active, issued January 4, 2017. It was issued by Cipher Pharmaceuticals Us Llc.
- Company
- Cipher Pharmaceuticals Us Llc
- Recall Initiated
- December 6, 2016
- Posted
- January 4, 2017
- Recall Number
- D-0237-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 216 boxes
- Firm Location
- Daniel Island, SC, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot #01316L02 6871201301
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