Multi-event July 2020 FDA Recall Drug by Allergan Plc

This Multi-event Class III drug recall was voluntarily initiated by Allergan Plc on July 6, 2020 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1409-2020 TERMINATED D-1410-2020 TERMINATED

Recall Number: D-1409-2020

Reason for Recall
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Initiated
07-06-2020
Reported
08-05-2020
Quantity
4,018 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85924
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.
Allergan PLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-28-2024
Product Description About Product Description
Full technical description of the product.
Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02

Batch or Lot Expiration Information

Lot# : 087293, Exp. Date 06/30/2020; 091356, Exp. Date 03/31/2021
Lot# : 093770, 093771, Exp. Date 07/31/2021

Recall Number: D-1410-2020

Reason for Recall
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Initiated
07-06-2020
Reported
08-05-2020
Quantity
8,555 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85924
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.
Allergan PLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-28-2024
Product Description About Product Description
Full technical description of the product.
Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005

Batch or Lot Expiration Information

Lot# : 090645A, 090645B, Exp. Date 07/31/2020; 090645C, Exp. Date 08/31/2020
Lot# : 090757A, Exp. Date 02/29/2020
Lot# 093199A, 093199B, 093199C, 093199D, Exp. Date 12/31/2020
Lot# : 096375A, 096375B, Exp. Date 06/30/2021
Lot# : 097455A, 097612A, Exp. Date 04/30/2021