FDA recall D-061-2013

Church & Dwight Inc · Class II · drug

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-09-06
Report date: 2012-11-28
Termination date: 2013-06-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

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