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.

FDA recall notice · announced November 28, 2012 · Church & Dwight

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 10310 32370 7.

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot #: BI1041, Exp 02/13
Quantity: 42,768 pumps
Status: Terminated
Products in this recall event:
- 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. (D-061-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.