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 Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL. packet. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6065. UPC 6 18029 80018 3
Lot numbers, UPCs & expiration codes
Product Code: 6065; Lots: 51450; EXP 9/19/2017; 52551, EXP 11/30/2017; 53180, EXP 1/16/2018; 54074, EXP3/11/2018; 54855, EXP 4/28/2018; 010437, EXP1/12/2019; 020637, EXP 2/14/2019; 51256, EXP 5/27/2018; 081066, EXP 8/25/2018; 090246, EXP 9/8/2018; 110026, 11/8/2018; 110625, EXP 11/19/2017.
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-0350-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Feb 21, 2018
- Quantity
- 7490 PACKETS
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sage Products Inc
Original FDA data
Every field from FDA enforcement report D-0350-2018, 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: 6065; Lots: 51450; EXP 9/19/2017; 52551, EXP 11/30/2017; 53180, EXP 1/16/2018; 54074, EXP3/11/2018; 54855, EXP 4/28/2018; 010437, EXP1/12/2019; 020637, EXP 2/14/2019; 51256, EXP 5/27/2018; 081066, EXP 8/25/2018; 090246, EXP 9/8/2018; 110026, 11/8/2018; 110625, EXP 11/19/2017.
- Postal code
- 60013-1804
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0350-2018
- Classification
- Class II
- Recalling firm
- Sage Products Inc
- Product quantity
- 7490 PACKETS
- 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 Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL. packet. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6065. UPC 6 18029 80018 3
- 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