December 2016 FDA Recall Drug by Cipher Pharmaceuticals Us Llc
D-0237-2017 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Cipher Pharmaceuticals Us Llc on December 6, 2016 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in AZ, CO and OH. and the recall is currently ongoing.

Recall Number: D-0237-2017

Reason for Recall
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Initiated
12-06-2016
Reported
01-04-2017
Quantity
216 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76011
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cipher Pharmaceuticals US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ, CO and OH.
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 01316L02 6871201301