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Terminated

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.

FDA Recall Z-2139-2019 · Posted None

Recalling FirmSage Products Inc
Recall StatusTerminated
Product CodeNSB
Date Initiated2018-12-05
Date Terminated2020-06-15
Product Quantity39 Cases (50 kits per case)

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.

Firm Action

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

Root Cause

Nonconforming Material/Component

Distribution Pattern

US nationwide distribution in the states CO, CT, GA, IN, CA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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