Cipher Pharmaceuticals Recalls Subpotent Inova Benzoyl Peroxide Pads
Cipher Pharmaceuticals is recalling 216 boxes of Inova benzoyl peroxide pads due to subpotent drug levels. The product was distributed in Arizona, Colorado, and Ohio.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent drug level, which is a documentation and specification issue rather than a direct safety threat like contamination or injury.
Plain-English summary
Cipher Pharmaceuticals US LLC is recalling 216 boxes of INOVA (benzoyl peroxide) 4% and Easy Pad (tocopherol) 5% for topical use. The recall is due to subpotent drug levels, where initial stability testing showed variation within the lot outside of product specifications.
The affected product is packaged in a box containing 30 pads of benzoyl peroxide 3g and 28 capsules of topical tocopherol 5%. It is an over-the-counter product manufactured for Innocutis Holdings, LLC. The specific lot number is 01316L02 6871201301.
The recalled product was distributed in Arizona, Colorado, and Ohio. Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- 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
- Manufacturer
- Cipher Pharmaceuticals US LLC
- Category
- Drug — Topical OTC
- Hazard
- Affected units
- 216
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #01316L02 6871201301
Distribution
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