Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Ch...
FDA Recall #D-061-2013 — Class II — September 6, 2012
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.
Reason for Recall
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Recalling Firm
Church & Dwight Inc — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
42,768 pumps
Distribution
Nationwide
Code Information
Lot #: BI1041, Exp 02/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated