hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distri
Summary
The FDA issued a Class II for hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluo by Colgate Palmolive Company. Reason: Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were .
Details
Source
Drug Recall
External ID
D-1084-2023
Action Date
2023-08-23
Status
Terminated
Category
drug
Product Description
hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry 3-pack overwrap UPC 8 19156 02349 4, UPC 10819156023491 case; in the variety 3-pack of Strawberry + Unicorn + Grape UPC 8 19156 02332 6, UPC 10819156023323 case; and in a 24-count Toothpaste Floorstand, UPC 819156020684 (case).
Lot/Code Info: Lot #: 004287, 2267USA94A, 2271USA94A, EXP 08/2024; 3053USA94A, Exp 01/2025; 3156USA94A, 3157USA94A, EXP 05/2025
Quantity Affected: 182,046 tubes
Reason for Recall
Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.
Distribution
Nationwide in the USSA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-10
Company
Piscataway, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Colgate Palmolive Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Colgate Palmolive Company have FDA actions?
This is the only FDA action we have on record for Colgate Palmolive Company in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1084-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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