Multi-event December 2017 FDA Recall Drug by Johnson & Johnson

This Multi-event Class II drug recall was voluntarily initiated by Johnson & Johnson on December 7, 2017 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0243-2018 TERMINATED D-0244-2018 TERMINATED D-0245-2018 TERMINATED

Recall Number: D-0243-2018

Reason for Recall
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Initiated
12-07-2017
Reported
02-07-2018
Quantity
67,260 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78610
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Johnson & Johnson
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.
Product was distributed nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2019
Product Description About Product Description
Full technical description of the product.
Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g) , Distributed by Johnson & Johnson Consumer Inc. Skillman, NJ 08558, UPC 0 70501 11131 4

Batch or Lot Expiration Information

Lot# : 16217F70, 16317F70, 18317F56, 18417F56, 18517F56, 18617F56, 19517F57 19617F57,19717F57, 19817F57, Exp. 05/2019.

Recall Number: D-0244-2018

Reason for Recall
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Initiated
12-07-2017
Reported
02-07-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78610
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Johnson & Johnson
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.
Product was distributed nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2019
Product Description About Product Description
Full technical description of the product.
Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can, NET WT. 5 OZ. (141 g) Distributed By: Johnson & Johnson Consumer Inc. Skillman, NJ 08558. UPC: 0 70501 10053 0

Batch or Lot Expiration Information

Lot# :15917F54, 16017F54, Exp. 05/2019; 15817F69,15917F69, Exp. 04/2019; 20017F55, 20117F55, Exp. 06/2019.

Recall Number: D-0245-2018

Reason for Recall
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Initiated
12-07-2017
Reported
02-07-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78610
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Johnson & Johnson
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.
Product was distributed nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2019
Product Description About Product Description
Full technical description of the product.
Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866

Batch or Lot Expiration Information

Lot# : 2617RT1, 2617RT2, 2627RT2, 2637RT1, 2647RT1, 2657RT1, 2627RT2, EXP 05/2019