Why it was recalled
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Product description
Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2
Lot numbers, UPCs & expiration codes
A6J231, expiration 08/2018; A6J261, expiration 08/2018; A6K171, expiration 08/2018; A6K241, expiration, 09/2018; A6M231, expiration 10/2018
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-0624-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 6, 2017
- FDA report date
- Apr 5, 2017
- Quantity
- 56,840 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GSK Consumer Healthcare
Original FDA data
Every field from FDA enforcement report D-0624-2017, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76662
- Address
- 184 Liberty Corner Rd Ste 200
- Code information
- A6J231, expiration 08/2018; A6J261, expiration 08/2018; A6K171, expiration 08/2018; A6K241, expiration, 09/2018; A6M231, expiration 10/2018
- Postal code
- 07059-6868
- Report date
- Apr 5, 2017
- Product type
- Drugs
- Recall number
- D-0624-2017
- Classification
- Class II
- Recalling firm
- GSK Consumer Healthcare
- Product quantity
- 56,840 cases
- Termination date
- May 31, 2018
- Reason for recall
- Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 6, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 30, 2017