FDA-Drug2012-11-28Class II

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.

Church & Dwight Inc
Hazard

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

Sold states
Nationwide
Affected count
42,768 pumps
Manufactured in
469 N Harrison St, N/A, Princeton, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-061-2013

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