Recalls / Class II
Class IID-0357-2018
Product
Toothette Oral Care Antiseptic Oral Rinse 1.5 fl.oz/44 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6122 UPC 6 18029 80079 4
- Affected lot / code info
- Product Code: 6122; Lots: 020387, EXP 02/13/2019; 041657, EXP 05/03/2019; 010507, EXP 01/16/2019; 050926, EXP 05/24/2018; 081026, EXP 08/24/2018; 090636, EXP 09/26/2018; 100176, 10/11/2018; 110575, EXP 11/24/2017; 10786, EXP 11/23/2018; 120936, EXP 12/21/2018. 110575
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
- 4,061 cases
- 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-0357-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.