Status
Terminated
Drug Enforcement D-061-2013
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Classification
Class II
Report Date
November 28, 2012
Termination Date
June 11, 2013
Product Information
- 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.
- Product quantity
- 42,768 pumps
- Reason for recall
- CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Church & Dwight Inc
- Address
-
469 N Harrison St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-061-2013
- Event ID
- 62461
- Recall initiation date
- September 6, 2012
- Center classification date
- November 21, 2012
- Code info
- Lot #: BI1041, Exp 02/13
- More code info
- —