Recalls / Class II

Class IID-0379-2018

Product

Toothette Oral Care Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer, Contains 2 Suctino Swabs with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6513

Affected lot / code info

Product Code: 6513; Lots: 51175, 51220, EXP 08/01/2017; 51570, EXP 08/15/2017; 51786, EXP 08/29/2017; 52104, EXP 09/19/2017; 52550, 52570,EXP 10/17/2017; 53460, EXP 12/12/2017, 53922, EXP 1/16/2018; 54161,EXP 02/06/2018; 54294, EXP 02/15/2018; 54395, EXP 02/20/2018; 54459,EXP 02/27/2018; 54963, EXP 03/28/2018; 54992, 55040, 55049, 55060, 55070, EXP 4/3/2018; 55486, 55617, EXP 05/08/2018; 56210, EXP 06/19/2018; 56772, 56777, EXP 07/24/2018; 57105, EXP 08/14/2018; 57329, EXP 08/21/2018; 57507, EXP09/05/2018; 58173, EXP 10/09/2018; 58429, EXP 10/24/2018; 59037, EXP 11/13/2018; 59549, EXP 12/11/2018; 59920, EXP 01/15/2019; 60566, EXP 02/19/2019; 60863, EXP 03/05/2019; 61292, EXP 04/02/2019; 61980, 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

42,628 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-0379-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.