Recalls / Class II

Class IID-0380-2018

Product

Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6550 6 18029 80065 7

Affected lot / code info

Product Code: 6550; Lots: 51590, EXP 08/15/2017; 52134, EXP 09/19/2017; 52179, EXP 09/26/2017; 52589, EXP 10/24/2017; 52966, EXP 11/07/2017; 53692, EXP 01/03/2018; 53883, EXP 01/16/2018; 54371, 54422, EXP 02/20/2018; 54622, 54677, EXP 03/06/2018; 54920, 54934, 54941, 54942, 54944, EXP 03/28/2018; 55296, EXP 04/17/2018; 55896, EXP 05/22/2018; 55925, 55934, 55951, EXP 05/30/2018; 56464, EXP 07/05/2018; 56936, EXP 08/07/2018; 57683, EXP 09/12/2018; 58244, EXP 10/16/2018; 58850, EXP 11/06/2018; 59283, EXP 11/20/2018; 59339, EXP 12/04/2018; 59636, EXP 12/18/2018; 59930, EXP 01/15/2019; 60592, 60648, EXP 02/26/2019; 60977, EXP 03/12/2019; 61022, EXP 03/19/2019; 61991, EXP 05/07/2019.

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

11194 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-0380-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.