FDA Recall D-0237-2017

Cipher Pharmaceuticals US LLC · Daniel Island, SC

Class III Ongoing 3446 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot #01316L02 6871201301

Quantity: 216 boxes

Reason for recall

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

Recall record

Recall number: D-0237-2017
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: AZ, CO and OH.
Recall initiated: 2016-12-06
Classified by FDA Center: 2016-12-28
FDA published: 2017-01-04
Recalling firm: Cipher Pharmaceuticals US LLC
Firm location: Daniel Island, SC

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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