FDA (Drugs) recall action 77992

Sage Products Inc recalled 64 products on 2018-02-21

The FDA (Drugs) publishes a recall like this one as 64 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 64 pages.

Products: 64
Announced: 2018-02-21
Critical: 0
Units: 470,694

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

26–50 of 64

ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Kits Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Daily Oral Cleansing Kits because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Daily Oral Cleansing Kit Petite Size with Antiseptic Oral Rinse. Contains: 10 Petite Size Oral Swabs, individually wrapped, 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
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Q.Care Oral System Recalled for Cross-Contamination Risk
Sage Products is recalling Q.Care Oral Cleansing Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, and Y-Connector, 2 Petit Size Suction Toothbrushes, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturizer, 4 Petit Size Untreated Suction Oral Swabs, 7ml Antiseptic Oral Rinse, Appli
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Suction Swab System
Sage Products Inc. is recalling the Toothette Oral Care Suction Swab System due to cross-contamination with non-pharmaceutical products during manufacturing.
Product
Toothette Oral Care Suction Swab System With Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Suction Swabs with sodium bicarbonate 0.25 fl oz/7ml Antiseptic Oral Rinse 0.7 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Roarald, Cary, IL 60013. Product Code
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination Risk
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.CareOral Cleansing & Suctioning System q2. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 O
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Q Care RX Oral System Recalled for Cross Contamination
Sage Products is recalling Q Care RX Oral Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab package
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls QCare RX Oral Cleansing System Due to Cross-Contamination
Sage Products is recalling 9,006 cases of QCare RX Oral Cleansing Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Product
QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Corinz. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 10 Suction Oral Swab packages with Corin
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Suction Toothbrush Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Suction Toothbrush kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. NDC: 53462-922-16
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination Risk
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint s
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Suction Swab System
Sage Products Inc. is recalling Toothette Oral Care Suction Swab Systems due to cross-contamination with non-pharmaceutical products during manufacturing.
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, 2 Packages of 1 Suction Toothbrush with sodium bicarbonate and a .25 fl oz/7ml pouch of Perox-A-
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination Risk
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab pack
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Systems Due to Cross-Contamination
Sage Products Inc. is recalling 879 cases of Toothette Oral Care Single Use Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml Antiseptic Oral Rinse, 0.7 fl oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Perox-A-Mint Solution
Sage Products is recalling Toothette Oral Care Perox-A-Mint Solution packets due to cross-contamination with non-pharmaceutical products during manufacturing.
Product
Toothette Oral Care Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL. packet. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6065. UPC 6 18029 80018 3
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage QCare Oral Cleansing System Recalled for Cross-Contamination Risk
Sage Products Inc. is recalling QCare Oral Cleansing and Suctioning Systems with Corinz due to cross-contamination with non-pharmaceutical products during manufacturing.
Product
QCare Oral Cleansing and Suctioning System with Corinz. Includes: Two (2) Suction Toothbrush packages with 0.25fl.oz/7mL Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and Four (4) Suction Oral Swab packages with 0.25 fl.oz/7mL Corinze Antiseptic Cleansing and Moisturizi
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Suction Toothbrush Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrush kits because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Toothette Oral Care Suction Toothbrush with Antiseptic Oral Rinse. Contains 1 Suction Toothbrush with sodium bicarbonate, 0.25 fl oz/ 7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Cod
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Q Care Oral Cleansing System Recalled for Cross-Contamination Risk
Sage Products is recalling Q Care Oral Cleansing & Suctioning System kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q Care, Oral Cleansing & Suctioning System Corinz. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 2 Or
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Oral Cleansing System Due to Cross-Contamination
Sage Products Inc. is recalling 20 cases of Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2, Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Packages Suction Oral Swab with sodium bicarbonate, Pe
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Oral Cleansing Systems Due to Cross-Contamination
Sage Products Inc. is recalling 25 cases of Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2, Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Packages Suction Oral Swab with sodium bicarbonate, Pe
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Chlorhexidine Skin and Oral Care Kits
Sage Products Inc. is recalling 150 cases of skin antisepsis and oral cleansing kits due to cross-contamination risks from shared manufacturing equipment.
Product
Skin antisepsis and oral cleansing. Contains Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Suction Handle, Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages wit
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Suction Toothbrushes Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 1 Suction toothbrush with sodium bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6571
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Systems Due to Cross-Contamination
Sage Products Inc. is recalling 835 cases of Toothette Oral Care Short Term Oral Swab Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, I Ultra-S
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Q CARE Oral System Recalled for Cross-Contamination Risk
Sage Products is recalling Q CARE q4 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Thr
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Products Recalls Corinz Oral Care Kits Due to Cross-Contamination
Sage Products is recalling 94 cases of Independent Care System Corinz oral care kits because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpast, 1 Ultra-Soft toothbrush. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6004 UPC 6 18029 821
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care System Due to Cross-Contamination
Sage Products Inc. is recalling the Toothette Oral Care Short Term Oral Care System because it was manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Short Term Oral Care System with Perox-A-Mint solution, Contains 1.5 fl oz/44 ml bottle of Perox-A-Mint solution, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpaste, 1 Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three O
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Q CARE Oral Cleaning System Due to Cross-Contamination
Sage Products is recalling Q CARE q4 Oral Cleaning & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q CARE q4 Oral Cleaning & Suctioning System Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6404 U
Category
Distribution
1 state