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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

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.
Recall Number D-061-2013
Classification Class II
Code Info Lot #: BI1041, Exp 02/13
Product Distributed Qty 42,768 pumps
Reason For Recall CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.

Event Detail

Event Id 62461
Product Type Drugs
Status Ongoing
Recalling Firm Church & Dwight Inc
City Princeton
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide