Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g)
Summary
The FDA issued a Class III for Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% by The Procter & Gamble Company. Reason: Labeling: Missing label: the product tube was missing a label and contained a different formulation..
Details
Source
Drug Recall
External ID
D-1290-2022
Action Date
2022-08-03
Status
Completed
Category
drug
Product Description
Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a) Individual carton, UPC 0 37000 598534; b) 5-count Bundle, UPC 037000171867, Distributed. By Procter & Gamble, Cincinnati, OH 45202.
Lot/Code Info: Lot: a) 13191707B4, Exp. 10/31/2023; b)13511707Y1, Exp. 10/31/2023.
Quantity Affected: 1,128 tubes
Reason for Recall
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Distribution
Washington State
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-08
Company
Cincinnati, OH
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 77 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
The Procter & Gamble Company has 27 FDA actions in our database, including 27 recalls.
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 (The Procter & Gamble Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Procter & Gamble Company have FDA actions?
The Procter & Gamble Company has 27 FDA actions in our database, including 27 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1290-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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