Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste and 1.5fl.oz. bottle of Corinz oral rinse. Product Usage: The mouthpaste is used to clean teeth, gums, and the tongue.
This recall has been terminated (originally issued December 5, 2018).
- Recall Initiated
- December 5, 2018
- Terminated
- June 15, 2020
- Recall Number
- Z-2139-2019
- Quantity
- 39 Cases (50 kits per case)
- Official Source
- View on FDA website ↗
Reason for Recall
A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.
Distribution
US nationwide distribution in the states CO, CT, GA, IN, CA.
Lot / Code Info
Product Code 6004; Lot Number 67924; Reorder Number 6080
Root Cause
Nonconforming Material/Component
Action Taken
Sage Products, LLC notified Distributor Partners/Healthcare Facilities on about 11/30/2018, via letter titled, "URGENT: RECALL Independent Care System: Product Code 6004." The letter instructed customers to examine their inventory for the affected lot number, discontinue use and/or further distribution of the affected lot, distributors that have distributed the product to facilities or customers should initiate a sub-recall process down to the facility or customer level, and complete and return the recall return response form. Questions can be directed to Customer Service at (800) 323-2200 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m., Central Time. The Recall Response forms should be returned to the following address: Sage Products LLC Attn: Missy Stefan Regulatory Affairs 3909 Three Oaks Road Cary, IL 60013