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.
D-061-2013
Product summary
- Event
- Event 62461
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42,768 pumps
- Official record key
drug-enforcement:D-061-2013
Official wording
Reason: CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Code information: Lot #: BI1041, Exp 02/13
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations