Why it was recalled
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
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.
Lot numbers, UPCs & expiration codes
Lot #: BI1041, Exp 02/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-061-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 6, 2012
- FDA report date
- Nov 28, 2012
- Quantity
- 42,768 pumps
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Church & Dwight Inc
Original FDA data
Every field from FDA enforcement report D-061-2013, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 62461
- Address
- 469 N Harrison St
- Code information
- Lot #: BI1041, Exp 02/13
- Postal code
- 08540-3510
- Report date
- Nov 28, 2012
- Product type
- Drugs
- Recall number
- D-061-2013
- Classification
- Class II
- Recalling firm
- Church & Dwight Inc
- Product quantity
- 42,768 pumps
- Termination date
- Jun 11, 2013
- Reason for recall
- CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 6, 2012
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2012