Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in ca
Summary
The FDA issued a Class III for Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-c by RB Health (US) LLC. Reason: Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging..
Details
Source
Drug Recall
External ID
D-1179-2023
Action Date
2023-10-04
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot # KT220211, Exp 07/2024
Quantity Affected: 6,072 cases/36,426 individual selling units
Reason for Recall
Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
Distribution
USA nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-29
Company
Parsippany, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 38 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
RB Health (US) LLC has 9 FDA actions in our database, including 1 recall and 8 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RB Health (US) LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RB Health (US) LLC have FDA actions?
RB Health (US) LLC has 9 FDA actions in our database, including 1 recall and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1179-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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