Why it was recalled
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Product description
Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6550 6 18029 80065 7
Lot numbers, UPCs & expiration codes
Product Code: 6550; Lots: 51590, EXP 08/15/2017; 52134, EXP 09/19/2017; 52179, EXP 09/26/2017; 52589, EXP 10/24/2017; 52966, EXP 11/07/2017; 53692, EXP 01/03/2018; 53883, EXP 01/16/2018; 54371, 54422, EXP 02/20/2018; 54622, 54677, EXP 03/06/2018; 54920, 54934, 54941, 54942, 54944, EXP 03/28/2018; 55296, EXP 04/17/2018; 55896, EXP 05/22/2018; 55925, 55934, 55951, EXP 05/30/2018; 56464, EXP 07/05/2018; 56936, EXP 08/07/2018; 57683, EXP 09/12/2018; 58244, EXP 10/16/2018; 58850, EXP 11/06/2018; 59283, EXP 11/20/2018; 59339, EXP 12/04/2018; 59636, EXP 12/18/2018; 59930, EXP 01/15/2019; 60592, 60648, EXP 02/26/2019; 60977, EXP 03/12/2019; 61022, EXP 03/19/2019; 61991, EXP 05/07/2019.
Where it was sold
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
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-0380-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Feb 21, 2018
- Quantity
- 11194 CASES
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sage Products Inc
Original FDA data
Every field from FDA enforcement report D-0380-2018, exactly as published.
Show all FDA fields
- City
- Cary
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77992
- Address
- 3909 3 Oaks Rd
- Code information
- Product Code: 6550; Lots: 51590, EXP 08/15/2017; 52134, EXP 09/19/2017; 52179, EXP 09/26/2017; 52589, EXP 10/24/2017; 52966, EXP 11/07/2017; 53692, EXP 01/03/2018; 53883, EXP 01/16/2018; 54371, 54422, EXP 02/20/2018; 54622, 54677, EXP 03/06/2018; 54920, 54934, 54941, 54942, 54944, EXP 03/28/2018; 55296, EXP 04/17/2018; 55896, EXP 05/22/2018; 55925, 55934, 55951, EXP 05/30/2018; 56464, EXP 07/05/2018; 56936, EXP 08/07/2018; 57683, EXP 09/12/2018; 58244, EXP 10/16/2018; 58850, EXP 11/06/2018; 59283, EXP 11/20/2018; 59339, EXP 12/04/2018; 59636, EXP 12/18/2018; 59930, EXP 01/15/2019; 60592, 60648, EXP 02/26/2019; 60977, EXP 03/12/2019; 61022, EXP 03/19/2019; 61991, EXP 05/07/2019.
- Postal code
- 60013-1804
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0380-2018
- Classification
- Class II
- Recalling firm
- Sage Products Inc
- Product quantity
- 11194 CASES
- Termination date
- Dec 13, 2018
- Reason for recall
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6550 6 18029 80065 7
- Distribution pattern
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- Recall initiation date
- Aug 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 9, 2018