January 2018 FDA Recall Drug by Oxygen Development Llc
D-0584-2018 - Superpotent drug

This Class III drug recall was voluntarily initiated by Oxygen Development Llc on January 24, 2018 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed in Canada and the recall is currently terminated.

Recall Number: D-0584-2018

Reason for Recall
Superpotent drug: failed assay throughout the stick after 6 months stability.
Initiated
01-24-2018
Reported
03-14-2018
Quantity
12216 sticks

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79338
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Oxygen Development 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 057800062653

Batch or Lot Expiration Information

Lot# : 060E