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…
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Q Care Oral Care Kits Due to Cross-Contamination
Sage Products is recalling Q Care Continue Care kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6308 UPC 6 18029 83040 1
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…
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Products Recalls Oral Cleansing Systems Due to Cross-Contamination
Sage Products Inc is recalling Oral Cleansing & Suctioning Systems with 0.12% Chlorexidine Gluconate Oral Rinse because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, packages SYS W/CHG 10, Sage Products, Inc., 3909…
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 QCare Rx Oral Cleansing System Recalled for Cross-Contamination
Sage Products Inc. is recalling QCare Rx Oral Cleansing and Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
QCare Rx Oral Cleansing and 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 Suction Oral Swab packages with…
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Swab System Due to Cross-Contamination
Sage Products Inc. is recalling the Toothette Short Term Oral Swab System because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Short Term Oral Swab System with Perox-A-Mint Solution. Contains: 20 Individually wrapped Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44mL bottle of Perox-A-Mint solution and One (1) 0.5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909…
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Suction Toothbrushes
Sage Products is recalling Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution due to potential cross-contamination with non-pharmaceutical products.
Product
Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 2 Suction Toothbrushes with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6570
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Oral Care Systems Due to Cross-Contamination
Sage Products Inc. is recalling Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
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 Packages Suction Oral Swab with sodium bicarbonate…
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…
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Systems Due to Cross-Contamination
Sage Products is recalling 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 Perox-A-Mint solution. Contains: 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml tube of Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6012 UPC (01)00618029800077
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Q Care RX Oral System Recalled for Cross-Contamination Risk
Sage Products is recalling Q Care RX Oral Cleansing Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 1 Single dose bottle of 0.12% CHG Oral Rinse, 2 Suction Oral Swab packages with Perox-A-Mint, 1…
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 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…
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Suction Toothbrushes
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrushes due to cross-contamination with non-pharmaceutical products during manufacturing.
Product
Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer, Contains 2 Suction Toothbrushes with sodium bicarbonate. 0.25 fl oz/7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013.…
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
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…
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Suction Swabs Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Suction Swabs because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
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
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…
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
SevereFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Systems Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Single Use Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Toothette Oral Care Single Use System with Perox-A-Mint solution and Mouth Moisturizer. Contains 2 Toothette Plus Swabs with sodium bicarbonate, .25 fl oz/7ml Perox-A-Mint solution and .07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013.…
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Perox-A-Mint Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Perox-A-Mint solution because it was manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6060 UPC (01)00618029800152
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 oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Contains 1 Suction Toothbrush with sodium Bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab, Sage Products, Inc., 3909 Three Oaks Road…
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Q.Care Oral System Recalled for Cross-Contamination Risk
Sage Products 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 q2. 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…
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination
Sage Products 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 q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint…
Category
Distribution
1 state