Recalls / Class II

Class IID-0360-2018

Product

Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product code 6000, UPC 6 18029 8001 5

Affected lot / code info

Lots:52115, EXP 08/04/2017; 52284, 52631, 53005, EXP 09/21/2017; 53012, 53343, EXP 12/02/2017; 53475, 53754, EXP 12/06/2017; 53765, 54130, 54146, 54158, 54166, 54179, 54502, EXP 01/19/2018; 54518, 54658, 54984, EXP 03/08/2018; 55063, 55540, 56029, EXP 04/25/2018; 56308, 56427, EXP 11/19/2017; 56442, 56620, EXP 05/27/2018; 56713, EXP 04/25/2018; 56737, 57067, 57325, EXP 05/27/2018; 57531, EXP 08/25/2018; 57932, 58115, EXP 09/08/2018; 58712, EXP 04/25/2018; 58757, 59015, EXP 09/14/2018; 59086, 59518, EXP 09/22/2018; 59565, 59764, EXP 11/22/2018; 60101, 60582, EXP 12/19/2018; 60637, EXP 01/23/2019; 61184, EXP 05/27/2018; 61195, 61654, EXP 01/23/2019;

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

25,409 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-0360-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.