Recalls / Class II
Class IID-0624-2017
Product
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
- Brand name
- Sensodyne
- Generic name
- Stannous Fluoride
- Active ingredient
- Stannous Fluoride
- Route
- Oral
- NDCs
- 0135-0547, 0135-0548, 0135-0575
- FDA application
- M022
- Affected lot / code info
- A6J231, expiration 08/2018; A6J261, expiration 08/2018; A6K171, expiration 08/2018; A6K241, expiration, 09/2018; A6M231, expiration 10/2018
Why it was recalled
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
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, Warren, New Jersey 07059-6868
Distribution
- Quantity
- 56,840 cases
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-03-06
- FDA classified
- 2017-03-30
- Posted by FDA
- 2017-04-05
- Terminated
- 2018-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0624-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.