Recalls / Class II

Class IID-0353-2018

Product

Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. NDC: 53462-922-16

Affected lot / code info

Product Code: 6512; Lots: 51381, EXP 8/8/2017; 51433, 51453, EXP 8/15/2017; 51931, EXP 9/12/17; 52754 EXP 10/31/2017; 53326, EXP 11/28/2017; 53826, EXP 1/9/2018; 54266, EXP /15/2018; 54606, EXP 3/6/2018; 54872, EXP 3/21/2018; 55310, 55319, EXP 4/17/2018; 55823, EXP 5/22/2018; 56030, EXP 6/5/2018; 56039, EXP 5/30/2018; 56054, EXP 6/5/2018; 56385, 56408, 56417, EXP 6/26/2018; 56424, 56432, 56440, 56450, EXP 7/5/2018; 56828, EXP 7/27/2018; 57436, EXP 8/29/2018; 57860, EXP 9/25/2018; 58010, EXP 10/2/2018; 58126, EXP 10/9/2018; 58753 EXP 11/6/2018; 59089, 59129, 59143, EXP 11/13/2018; 59762, EXP 1/2/2019; 60261, 60308, EXP 1/22/2019; 60957, EXP 3/12/2019; 61411 EXP 4/9/2019; 61715, EXP 4/23/2019.

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

38,792 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-0353-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.