Recalls / Class II
Class IID-061-2013
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.
- Affected lot / code info
- Lot #: BI1041, Exp 02/13
Why it was recalled
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Recalling firm
- Firm
- Church & Dwight Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 469 N Harrison St, N/A, Princeton, New Jersey 08540-3510
Distribution
- Quantity
- 42,768 pumps
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-09-06
- FDA classified
- 2012-11-21
- Posted by FDA
- 2012-11-28
- Terminated
- 2013-06-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-061-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.