RecallRadar

FDA Drug recall D-0367-2018

Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate,…

On 2018-02-21 the FDA classified a Class II recall of Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate,… by Sage Products, citing cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0367-2018
ClassificationClass II
Statusterminated
Initiated2017-08-22
Published2018-02-21
Last updated2026-09-13 11:52 UTC
CompanySage Products
DistributionUS

Product

Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl oz/44ml bottle of Antiseptic Oral Rinse, .5 oz.14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6100 UPC (01)00618029820969

Reason

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

Identifiers

code_info
Product Code: 6100; Lots: 57856, 58296, 58814, EXP 11/24/2017; 54496, 55225, 56214, EXP 02/06/2018; 56280, 57109, 5828…Product Code: 6100; Lots: 57856, 58296, 58814, EXP 11/24/2017; 54496, 55225, 56214, EXP 02/06/2018; 56280, 57109, 58288, EXP 04/12/2018; 59175, 59487, 60187, EXP 05/23/2018; 58815, 59157, EXP 05/24/2018; 61262, 61740, EXP 02/10/2019.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0367-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.