Why it was recalled
Presence of Foreign Substance: possibility of the presence of metal in the product.
Product description
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.
Lot numbers, UPCs & expiration codes
G7E101, Exp 04/19
Where it was sold
Nationwide in the USA
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-0944-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 28, 2017
- FDA report date
- Jul 12, 2017
- Quantity
- 15,708 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GSK Consumer Healthcare
Original FDA data
Every field from FDA enforcement report D-0944-2017, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77651
- Address
- 184 Liberty Corner Rd Ste 200
- Code information
- G7E101, Exp 04/19
- Postal code
- 07059-6868
- Report date
- Jul 12, 2017
- Product type
- Drugs
- Recall number
- D-0944-2017
- Classification
- Class II
- Recalling firm
- GSK Consumer Healthcare
- Product quantity
- 15,708 tubes
- Termination date
- Feb 7, 2020
- Reason for recall
- Presence of Foreign Substance: possibility of the presence of metal in the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 28, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 6, 2017