FDAClass IIRecall started September 6, 2012

Orajel Kids My Way! Anticavity Fluoride toothpaste 0.24% Recall: CGMP Deviations

Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3…

What is the FDA recall status?

The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.

How FDA enforcement data reports status

Why was Orajel Kids My Way! Anticavity Fluoride toothpaste recalled?

CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7.

Which lot codes, UPCs or models are affected?

Lot #: BI1041, Exp 02/13

Agency record number
D-061-2013
Product
Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3…
Recalling firm
Church & Dwight Inc
Quantity
42,768 pumps
Distribution
Nationwide
Recall started
September 6, 2012
Report date
November 28, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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