Recalls / Class II
Class IID-0944-2017
Product
parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01.
- Brand name
- Parodontax
- Generic name
- Stannous Fluoride
- Active ingredient
- Stannous Fluoride
- Route
- Dental
- NDCs
- 0135-0598, 0135-0599, 0135-0601
- FDA application
- M022
- Affected lot / code info
- G7E101, Exp 04/19
Why it was recalled
Presence of Foreign Substance: possibility of the presence of metal in the product.
Recalling firm
- Firm
- GSK Consumer Healthcare
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 184 Liberty Corner Rd Ste 200, N/A, Warren, New Jersey 07059-6868
Distribution
- Quantity
- 15,708 tubes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-06-28
- FDA classified
- 2017-07-06
- Posted by FDA
- 2017-07-12
- Terminated
- 2020-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0944-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.