Recalls / Class II
Class IID-0350-2018
Product
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
- Affected lot / code info
- 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.
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
Recalling firm
- Firm
- Sage Products Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3909 3 Oaks Rd, Cary, Illinois 60013-1804
Distribution
- Quantity
- 7490 PACKETS
- Distribution pattern
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Timeline
- Recall initiated
- 2017-08-22
- FDA classified
- 2018-02-09
- Posted by FDA
- 2018-02-21
- Terminated
- 2018-12-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0350-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.