August 2023 FDA Recall Clearasil Rapid Rescue Deep Treatment Pads by Rb Health (us) Llc (D-1179-2023 - Labeling)

This Class III drug recall was voluntarily initiated by Rb Health (us) Llc on August 29, 2023 for the product Clearasil Rapid Rescue Deep Treatment Pads. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1179-2023

Reason for Recall
Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
Initiated
08-29-2023
Reported
10-04-2023
Quantity
6,072 cases/36,426 individual selling units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92977
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.
RB Health (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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2025
Product Description About Product Description
Full technical description of the product.
Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6 jars per case, Distributed by RB Health (US), Parsippany, NJ 07054, NDC 63824-431-90

Batch or Lot Expiration Information

Lot# KT220211, Exp 07/2024

Affected Packages Involved in this Recall

63824-431-90 Clearasil Rapid Rescue Deep Treatment Pads