Multi-event August 2017 FDA Recall Drug by Sage Products Inc

This Multi-event Class II drug recall was voluntarily initiated by Sage Products Inc on August 22, 2017 for the product Drug. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0390-2018 TERMINATED D-0410-2018 TERMINATED D-0386-2018 TERMINATED D-0388-2018 TERMINATED D-0404-2018 TERMINATED D-0357-2018 TERMINATED D-0358-2018 TERMINATED D-0396-2018 TERMINATED D-0380-2018 TERMINATED D-0400-2018 TERMINATED D-0381-2018 TERMINATED D-0362-2018 TERMINATED D-0411-2018 TERMINATED D-0378-2018 TERMINATED D-0373-2018 TERMINATED D-0375-2018 TERMINATED D-0379-2018 TERMINATED D-0361-2018 TERMINATED D-0369-2018 TERMINATED D-0405-2018 TERMINATED D-0389-2018 TERMINATED D-0366-2018 TERMINATED D-0395-2018 TERMINATED D-0368-2018 TERMINATED D-0354-2018 TERMINATED D-0407-2018 TERMINATED D-0365-2018 TERMINATED D-0350-2018 TERMINATED D-0364-2018 TERMINATED D-0371-2018 TERMINATED D-0383-2018 TERMINATED D-0398-2018 TERMINATED D-0403-2018 TERMINATED D-0363-2018 TERMINATED D-0406-2018 TERMINATED D-0401-2018 TERMINATED D-0377-2018 TERMINATED D-0367-2018 TERMINATED D-0349-2018 TERMINATED D-0397-2018 TERMINATED D-0356-2018 TERMINATED D-0402-2018 TERMINATED D-0360-2018 TERMINATED D-0391-2018 TERMINATED D-0351-2018 TERMINATED D-0376-2018 TERMINATED D-0370-2018 TERMINATED D-0353-2018 TERMINATED D-0359-2018 TERMINATED D-0394-2018 TERMINATED D-0392-2018 TERMINATED D-0393-2018 TERMINATED D-0399-2018 TERMINATED D-0408-2018 TERMINATED D-0372-2018 TERMINATED D-0387-2018 TERMINATED D-0352-2018 TERMINATED D-0348-2018 TERMINATED D-0385-2018 TERMINATED D-0382-2018 TERMINATED D-0374-2018 TERMINATED D-0355-2018 TERMINATED D-0384-2018 TERMINATED D-0409-2018 TERMINATED

Recall Number: D-0390-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
4650 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Toothette Oral Care Suction Swabs with Perox-A-Mint solution. Contains 2 Suction Swabs 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, Cary, IL 60013. Product Code 6613

Batch or Lot Expiration Information

Lot# Product Code: 6613; Lots: 51330, EXP 08/08/2017; 52400, EXP 10/03/2017; 53198, EXP 11/28/2017; 54582, EXP 02/27/2018; 55837, EXP 05/22/2018, 57007, EXP 08/07/2018; 57904, EXP 09/25/2018; 58931, EXP 11/06/2018.

Recall Number: D-0410-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
150 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Bicarbonate. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9009 UPC 6 18029 79140 5

Batch or Lot Expiration Information

Lot# Product Code: 9009; Lots: 60354, EXP 04/01/2018.

Recall Number: D-0386-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
25 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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, Perox-A-Mint solution and Mouth Moisturizer, 6 Packages Suction Oral Swab with sodium bicarbonate, Alcohol Free Mouthwash and Mouth Moisturizer, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6592-S UPC 6 18029 82133 1

Batch or Lot Expiration Information

Lot# Product Code: 6592-S; Lots: 62154 EXP 02/19/2019

Recall Number: D-0388-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
20 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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, Perox-A-Mint solution and Mouth Moisturizer, , 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6594-S UPC 6 18029 82134 1

Batch or Lot Expiration Information

Lot# Product Code: 6594-S; Lots:52348, EXP 08/08/2017.

Recall Number: D-0404-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
16639 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6924 UPC 6 18029 83033 3

Batch or Lot Expiration Information

Lot# Product Code: 6924; Lots: 51601, EXP 08/15/2017; 52138, EXP 09/19/2017; 52836, 52935, EXP 11/07/2017; 53531, EXP 12/12/2017; 53788, EXP 01/09/2018; 54388, EXP 02/20/2018; 54796, 54816, EXP 3/13/2018; 55130, 55171, EXP 04/03/2018; 55323, EXP 04/17/2018; 55400, EXP 04/24/2018; 56049, EXP 06/05/2018; 56191, EXP 06/12/2018; 56330, EXP 06/19/2018; 56856, EXP 07/31/2018; 57437, EXP 08/29/2018; 57876, EXP 09/25/2018; 58707, EXP 11/06/2018; 59126, EXP 11/13/2018; 59607, EXP 12/11/2018; 60255, EXP 11/27/2018; 60273, EXP 01/22/2019; 60871, 03/05/2019; 61058, EXP 03/19/2019; 61676, EXP 04/23/2019.

Recall Number: D-0357-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
4,061 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Toothette Oral Care Antiseptic Oral Rinse 1.5 fl.oz/44 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6122 UPC 6 18029 80079 4

Batch or Lot Expiration Information

Lot# Product Code: 6122; Lots: 020387, EXP 02/13/2019; 041657, EXP 05/03/2019; 010507, EXP 01/16/2019; 050926, EXP 05/24/2018; 081026, EXP 08/24/2018; 090636, EXP 09/26/2018; 100176, 10/11/2018; 110575, EXP 11/24/2017; 10786, EXP 11/23/2018; 120936, EXP 12/21/2018. 110575

Recall Number: D-0358-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
2,429 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6001, UPC (01)00618029800039

Batch or Lot Expiration Information

Lot# Product Code: 6001; Lots: 52267, EXP 08/04/2017; 52278, 52974, 09/21/2017; 53633, 53661, 53663, 53667, EXP 12/06/2017; 54107, EXP 01/19/2018; 55208, EXP 04/25/2018; 56290, EXP 11/19/2017; 56815, EXP 05/27/2018; 57889, EXP 09/08/2018; 58819 EXP 09/14/2018; 59332, EXP 09/22/2018; 60214, EXP 11/22/2018; 61607, EXP 01/23/2019; 62124, EXP 02/14/2019.

Recall Number: D-0396-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
5085 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Q.CARE Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Toothbrush packages with Antiplaque solution. 4 Suction Oral Swab packages with Perox-A-Mint solution. 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6804 UPC 6 18029 84121 6

Batch or Lot Expiration Information

Lot# Product Code: 6804; Lots: 57567, EXP 08/14/2017; 58163, EXP 09/11/2017; 59009, EXP 11/03/2017; 59637, EXP 11/27/2017; 60241, 60263, EXP 01/02/2018; 60631, EXP 02/05/2018; 61294,EXP 02/23/2018; 61321, EXP 03/30/2018.

Recall Number: D-0380-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
11194 CASES

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6550 6 18029 80065 7

Batch or Lot Expiration Information

Lot# Product Code: 6550; Lots: 51590, EXP 08/15/2017; 52134, EXP 09/19/2017; 52179, EXP 09/26/2017; 52589, EXP 10/24/2017; 52966, EXP 11/07/2017; 53692, EXP 01/03/2018; 53883, EXP 01/16/2018; 54371, 54422, EXP 02/20/2018; 54622, 54677, EXP 03/06/2018; 54920, 54934, 54941, 54942, 54944, EXP 03/28/2018; 55296, EXP 04/17/2018; 55896, EXP 05/22/2018; 55925, 55934, 55951, EXP 05/30/2018; 56464, EXP 07/05/2018; 56936, EXP 08/07/2018; 57683, EXP 09/12/2018; 58244, EXP 10/16/2018; 58850, EXP 11/06/2018; 59283, EXP 11/20/2018; 59339, EXP 12/04/2018; 59636, EXP 12/18/2018; 59930, EXP 01/15/2019; 60592, 60648, EXP 02/26/2019; 60977, EXP 03/12/2019; 61022, EXP 03/19/2019; 61991, EXP 05/07/2019.

Recall Number: D-0400-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
82072 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 solution, 2 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6914 UPC 6 18029 83017 3

Batch or Lot Expiration Information

Lot# Product Code: 6914; Lots: 52775, 52877, 52932, 53050, 53143, 53290, 53337, EXP 08/31/2017; 53345, 53418, 53454, 53488, 53609, 53830, 55373 EXP 09/30/2017; 53869, 53982, 53991, 53992, 53995, 54004, 54016, 54025, 54126, 54241, 54292, 54380, 54471, 54490, EXP 10/31/2017; 54504, 54594, 54674, EXP 12/31/2017; 54841, 54867, 54974, 55108, EXP 11/30/2017; 55237, 55307, 55362, 55392, 55652, 55684, 55774, 55842, 56003, 56099, 56149, 56212, 56244, EXP 12/31/2017; 56285, 56467, 56538, 56545, 56553, 56563, 56578, 56720, 56747, 56758, 56768, 56779, 56798, 56811, 56881, 56935, 56990, 57038, 57103, 57266, 57470, 57327, EXP 02/28/2018; 57380, 57444, 57476, 57640, 57699, 57769, 57810, EXP 03/31/2018; 57862, 57990, 58055, 58128, 58172, 58333, 58390, 58418, EXP 04/30/2018; 58460, 58538, 58589, 58645, 58887, 58941, EXP 06/30/2018; 59171, 59275, 59350, 59403, 59616, 59684, EXP 07/31/2018; 59745, 59916, 59964, 60015, 60095, 60180, 60254, EXP 08/31/2018; 60451, 60521, 60763, 60833, 60885, 61045, EXP 09/30/2018; 61069, 61618, 61697, 61879, 61932, 61979, 62026, 62057, 62246, 61128, EXP 12/31/2018

Recall Number: D-0381-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
5303 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6552 UPC 6 18029 82115 7

Batch or Lot Expiration Information

Lot# Product Code: 6552; Lots: 52573, 52926, 53596, EXP 10/03/2017; 53610, 54288, EXP 12/19/2017; 54723, EXP 02/27/2018; 55878, 55890, 56617, 56637, EXP 04/24/2018; 56644, 56647, 56652, 57299, 57317, EXP 06/12/2018; 57305, EXP 05/08/2018; 57321, 60919, 61943, 58386, EXP 08/07/2018; 58398, EXP 10/02/2018; 59723, EXP 10/16/2018; 59739, EXP 12/11/2018

Recall Number: D-0362-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
94 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 82148 5

Batch or Lot Expiration Information

Lot# Product Code: 6004; Lots: 61610, EXP 11/17/2018

Recall Number: D-0411-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. 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 Bicarbonate. 1 Bottle of 3M Skin and Nasal Antiseptic (Povidone-Iodine Solution 5%w/w (0.5%available iodine) USP) Patient Preoperative Skin Preparation 0.14 fl oz (4ml), 4 sterile swabs. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9010 UPC 6 18029 79139 9

Batch or Lot Expiration Information

Lot# Product Code: 9010; Lots: 60298, 60352, EXP 04/01/2018

Recall Number: D-0378-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
852 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint- solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6502 UPC 6 18029 80060 2

Batch or Lot Expiration Information

Lot# Product Code: 6502; Lots: 57627, EXP 08/14/2017; 58677, EXP 10/02/2017; 60110, EXP 01/02/2018; 61463, EXP 03/30/2018.

Recall Number: D-0373-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
2,194 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 UPC 6 18029 84133 9

Batch or Lot Expiration Information

Lot# Product Code: 6404; Lots: 58394, EXP 10/02/2017; 59185, EXP 11/03/2017; 59782, EXP 11/27/2017; 59799, EXP 01/02/2018; 60776, EXP 01/22/2018; 61185, EXP 02/23/2018.

Recall Number: D-0375-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
13,041 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Three Oaks Road, Cary, IL 60013. Product Code 6414 UPC 6 18029 84138 4

Batch or Lot Expiration Information

Lot# Product Code: 6414; Lots: 57847, EXP 09/18/2017; 57852, 57875, EXP 08/14/2017; 58246, EXP 09/20/2017; 58802, 58851, EXP 10/09/2017; 58924, 59091, 59116, EXP 11/03/2017; 59494, EXP 11/27/2017; 60123, EXP 01/02/2018; 60466, 60880, 60925, 01/22/2018; 61364, 03/05/2018; 61705, EXP03/30/2018; 62061, EXP 04/17/2018; 62076, EXP 04/27/2018

Recall Number: D-0379-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
42,628 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Product Code: 6513; Lots: 51175, 51220, EXP 08/01/2017; 51570, EXP 08/15/2017; 51786, EXP 08/29/2017; 52104, EXP 09/19/2017; 52550, 52570,EXP 10/17/2017; 53460, EXP 12/12/2017, 53922, EXP 1/16/2018; 54161,EXP 02/06/2018; 54294, EXP 02/15/2018; 54395, EXP 02/20/2018; 54459,EXP 02/27/2018; 54963, EXP 03/28/2018; 54992, 55040, 55049, 55060, 55070, EXP 4/3/2018; 55486, 55617, EXP 05/08/2018; 56210, EXP 06/19/2018; 56772, 56777, EXP 07/24/2018; 57105, EXP 08/14/2018; 57329, EXP 08/21/2018; 57507, EXP09/05/2018; 58173, EXP 10/09/2018; 58429, EXP 10/24/2018; 59037, EXP 11/13/2018; 59549, EXP 12/11/2018; 59920, EXP 01/15/2019; 60566, EXP 02/19/2019; 60863, EXP 03/05/2019; 61292, EXP 04/02/2019; 61980, EXP 05/07/2019.

Recall Number: D-0361-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
849 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Oaks Road, Cary, IL 60013. Product Code 6002-D UPC (01)00618029821461

Batch or Lot Expiration Information

Lot# Product Code: 6002-D; Lots: 57942, EXP 09/08/2018; 58186, 58673, EXP 09/14/2018; 60297, EXP 12/19/2018; 61893, EXP 02/14/2019.

Recall Number: D-0369-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
879 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Code 6113 UPC (01)00618029820990

Batch or Lot Expiration Information

Lot# Product Code: 6113; Lots: 57874, EXP 09/19/2017; 58903, EXP 11/15/2017; 60045, EXP 01/08/2018; 61109, EXP 01/22/2018.

Recall Number: D-0405-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
3928 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6964 UPC 6 18029 83075 3

Batch or Lot Expiration Information

Lot# Product Code: 6964; Lots: 56718, EXP 09/26/2017; 57387, 57414, 57423, EXP 11/13/2017; 58272, EXP 04/03/2018; 59592, EXP 07/16/2018; 60142, EXP 08/02/2018; 60541, EXP 09/04/2018; 60767, EXP 09/06/2018; 61159, EXP 09/11/2018; 61467, EXP 10/16/2018; 62075, EXP 11/12/2018.

Recall Number: D-0389-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
2408 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Toothette Oral Care Q Care & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Perox-A-Mint solution, 10 Suction Oral Swab packages with Perox-A-Mint solution, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6602 UPC 6 18029 84116 2

Batch or Lot Expiration Information

Lot# Product Code: 6602; Lots: 52005, EXP 09/12/2017; 52917, EXP 11/07/2017; 53327, EXP 12/05/2017; 54186, EXP 02/06/2018; 55327, EXP 04/17/2018; 56169, EXP 06/12/2018; 57385, EXP 08/29/2018; 58564, EXP 10/30/2018; 60205, EXP 11/27/2018; 61033, EXP 03/19/2019; 61443, EXP 04/09/2019.

Recall Number: D-0366-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
945 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Product Code: 6060; Lots: 53057, EXP 12/7/2017; 57537, 59140, 60722, EXP 5/23/2017.

Recall Number: D-0395-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
2970 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6802 UPC 6 18029 84120 9

Batch or Lot Expiration Information

Lot# Product Code: 6802; Lots: 57509, EXP 08/14/2017; 58122, EXP 09/11/2017; 58203, EXP 10/02/2017; 58978, EXP 11/03/2018; 59724, EXP 11/27/2017; 60556, EXP 02/05/2018; 61241, EXP 02/23/2018

Recall Number: D-0368-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
640 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 6115

Batch or Lot Expiration Information

Lot# Product Code: 6115; Lots: 58483, EXP 10/09/2017; 59783, EXP 01/08/2018; 61117, EXP 03/05/2018.

Recall Number: D-0354-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
9,006 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6962, UPC 6 18029 83076 0

Batch or Lot Expiration Information

Lot# Product Code: 6962; Lots: 55604, 55619, 56000, 56052 EXP 08/28/2017; 56211, 56282, 56783, EXP 09/26/2017; 57204, 57614, 58027, EXP 11/13/2017; 58549, 58587, EXP 04/03/2018; 59493, EXP 07/16/2018; 60043, 60079, EXP 07/30/2018; 60476, EXPO 08/02/2018; 60490 EXP 09/04/2018; 60790, EXP 09/06/2018; 61405, EXP 09/11/2018; 61456, 61799, EXP 10/16/2018

Recall Number: D-0407-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
25 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974-S UPC 6 18029 83097 5

Batch or Lot Expiration Information

Lot# Product Code: 6974-S; Lots: 58317, EXP 04/03/2018.

Recall Number: D-0365-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
15,644 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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. Product Code 6013 UPC 6 18029 80008 4

Batch or Lot Expiration Information

Lot# Product Code: 6013; Lots: 51361, EXP 8/8/2017; 51834, EXP 9/6/2017; 52473, EXP 10/17/2017; 53225, EXP 11/28/2017; 54102, EXP 1/30/2018; 54754, EXP 3/13/2018; 55222, 55264, EXP 4/10/2018, 56683, EXP 7/17/2018; 57262, EXP 8/21/2018; 57803, EXP 9/18/2018; 58492, EXP 10/30/2018; 59311, EXP 12/4/2018; 60069, EXP 11/27/2018; 61063, EXP 3/19/2019; 61629, EXP 4/17/2019.

Recall Number: D-0350-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
7490 PACKETS

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Product Code: 6065; Lots: 51450; EXP 9/19/2017; 52551, EXP 11/30/2017; 53180, EXP 1/16/2018; 54074, EXP3/11/2018; 54855, EXP 4/28/2018; 010437, EXP1/12/2019; 020637, EXP 2/14/2019; 51256, EXP 5/27/2018; 081066, EXP 8/25/2018; 090246, EXP 9/8/2018; 110026, 11/8/2018; 110625, EXP 11/19/2017.

Recall Number: D-0364-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
14,753 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Product Code: 6012; Lots: 51502, EXP 08/15/2017; 51883, 09/06/2017; 53585, EXP12/19/2018; 54222, 54226, EXP 02/06/2018; 54811, EXP 03/21/2018; 55574, EXP 05/08/2018; 56190, EXP 06/12/2018; 56346, EXP 06/26/2018; 56616, EXP 07/12/2018; 57066, EXP 08/07/2018; 57873, EXP 09/25/2018; 58634, EXP 08/28/2018; 58664, EXP 11/06/2018; 59719, EXP 01/02/2019; 61340, EXP 04/02/2019; 62326, EXP 06/11/2019

Recall Number: D-0371-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
5,217 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6306 UPC 6 18029 83041 8

Batch or Lot Expiration Information

Lot# Product Code: 6306; Lots: 55203, 55207, 55505, EXP 08/28/2017; 56466, 56502, 56508, 56515, EXP 09/26/2017; 57265, EXP 11/13/2017; 58129, EXP 12/11/2017; 59085, EXP 6/15/2018; 59742, EXP 7/16/2018 60163, EXP 08/02/2018; 60834, 61371, 61402, EXP 09/11/2018; 61913, EXP 11/12/2018.

Recall Number: D-0383-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
8466 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Product Code: 6571; Lots: 52384, EXP 10/03/2018; 53134, EXP 11/28/2017; 53387, EXP 12/05/2017; 54215, EXP 02/06/2018; 54967, EXP 03/28/2018; 55997, EXP 05/30/2018; 56180, EXP 06/12/2018; 56854, EXP 07/31/2018; 57334, EXP 08/21/2018; 58305, EXP 10/16/2018; 59844, EXP 01/08/2019; 60753, 60761, 60772, 60780, 60788,EXP 03/05/2019; 61664, EXP 04/23/2019; 62156, EXP 05/14/2019.

Recall Number: D-0398-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
6130 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6904 UPC 6 18029 83008 1

Batch or Lot Expiration Information

Lot# Product Code: 6904; Lots: 52850, 53281, EXP 08/31/2017; 53300, 53579, EXP 09/30/2017; 54320, EXP 10/31/2017; 54960, EXP 11/30/2017; 55753, EXP 12/31/2017; 56914, EXP 02/28/2018; 57352, EXP 04/30/2018; 57836, EXP 03/31/2018; 58349, EXP 04/30/2018; 59578, EXP 07/31/2018; 60712, EXP 09/30/2018; 61274, EXP 12/31/2018.

Recall Number: D-0403-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
480 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6922-B UPC 6 18029 83032 6

Batch or Lot Expiration Information

Lot# Product Code: 6922-B; Lots: 53070, EXP 08/31/2017; 54452, EXP 10/31/2017; 56283, EXP 12/31/2017; 57710, EXP 02/28/2018; 58350, EXP 04/30/2018; 59528, 59539 EXP 07/31/2018; 60468, EXP 08/31/2018.

Recall Number: D-0363-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
637 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 60013. Product Code 6006 UPC (01)00618029800053

Batch or Lot Expiration Information

Lot# Product Code: 6006; Lots: 54523,54629, 55528, EXP 02/06/2018; 56864, 57915, EXP 04/12/2018; 58884, 60137, 61047, EXP 05/23/2018; 61123, EXP 02/10/2019

Recall Number: D-0406-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
633 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974 UPC 6 18029 83097 5

Batch or Lot Expiration Information

Lot# Product Code: 6974; Lots: 58322, 58649, EXP 04/03/2018; 60186, EXP 08/02/2018; 60747, EXP 09/06/2018.

Recall Number: D-0401-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
60 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 solution, 2 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6914-S UPC 6 18029 83017 3

Batch or Lot Expiration Information

Lot# Product Code: 6914-S; Lots: 52435, EXP 10/03/2017, 57750, EXP 09/18/2018.

Recall Number: D-0377-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
9,110 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6424 UPC 6 18029 83027 2

Batch or Lot Expiration Information

Lot# Product Code: 6424; Lots: 57386, EXP 08/14/2017; 58035, EXP 09/11/2017; 58363, 58566, 58582, EXP 10/02/2017; 58760, 58889, EXP 11/03/2017; 59288, EXP 11/13/2017; 59467, EXP 11/27/2017; 59983, 60094, EXP 01/02/2018; 60324, EXP 02/05/2018; 61001, EXP 02/23/2018.

Recall Number: D-0367-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
2,548 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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.

Recall Number: D-0349-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Oropharyngeal Suction Cather packages. Manufactured by: Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013

Batch or Lot Expiration Information

Lot# Product Code: 6462; Lots: 55152, EXP 08/28/2017; 57055, EXP 09/26/2017; 57078, EXP 11/13/2017; 58213, EXP 12/22/2017; 58255, EXP 04/02/2018, 59031, EXP 04/03/2018; 59036, 59087, EXP 06/15/2018; 59781, EXP 07/30/2018; 59803, EXP 07/16/2018.

Recall Number: D-0397-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
2468 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Q.Care Oral Cleansing & Suctioning System q8. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 1 Suction Oral Swab packages with Perox-A-Mint solution, 1 Oropharyngeal Suction Catheter package. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6808 UPC 6 18029 84122 3

Batch or Lot Expiration Information

Lot# Product Code: 6808; Lots: 57592, EXP 08/14/2017; 58202, EXP 10/02/2017; 59213, EXP 11/13/2017; 60274, EXP 01/02/2018; 60718 EXP 02/05/2018; 61745, EXP 03/21/2018.

Recall Number: D-0356-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
2,199 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino Toothbrush packages with Antiplaque solution, 4)Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6504. UPC 6 18029 83045 6

Batch or Lot Expiration Information

Lot# Product Code: 6504; Lots: 58174, EXP 09/11/2017; 59297, EXP 11/13/2017; 60127, EXP 01/02/2018; 60673, EXP 02/05/2018; 61002, EXP 02/23/2018; 61817, EXP 03/21/2018; 61825, EXP 04/27/2018

Recall Number: D-0402-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
6461 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6922 UPC 6 18029 83032 6

Batch or Lot Expiration Information

Lot# Product Code: 6922; Lots: 51408, EXP 08/10/2017; 51701, EXP 08/22/2017; 52782, EXP 10/31/2018; 53083, EXP 11/14/2017; 53746, EXP 01/09/2018; 54210, EXP 02/06/2018; 54868, EXP 03/21/2018; 55294, XP 04/17/2018; 55930, EXP 05/30/2018;56555, EXP 07/12/2018; 57519, EXP 09/05/2018; 58373, EXP 10/16/2018; 59542, EXP 12/11/20178; 60611, EXP 02/26/2019; 61148, EXP 03/26/2019; 61623, EXP 04/17/2019

Recall Number: D-0360-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
25,409 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product code 6000, UPC 6 18029 8001 5

Batch or Lot Expiration Information

Lot# Lots:52115, EXP 08/04/2017; 52284, 52631, 53005, EXP 09/21/2017; 53012, 53343, EXP 12/02/2017; 53475, 53754, EXP 12/06/2017; 53765, 54130, 54146, 54158, 54166, 54179, 54502, EXP 01/19/2018; 54518, 54658, 54984, EXP 03/08/2018; 55063, 55540, 56029, EXP 04/25/2018; 56308, 56427, EXP 11/19/2017; 56442, 56620, EXP 05/27/2018; 56713, EXP 04/25/2018; 56737, 57067, 57325, EXP 05/27/2018; 57531, EXP 08/25/2018; 57932, 58115, EXP 09/08/2018; 58712, EXP 04/25/2018; 58757, 59015, EXP 09/14/2018; 59086, 59518, EXP 09/22/2018; 59565, 59764, EXP 11/22/2018; 60101, 60582, EXP 12/19/2018; 60637, EXP 01/23/2019; 61184, EXP 05/27/2018; 61195, 61654, EXP 01/23/2019

Recall Number: D-0391-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
4255 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution. 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, Cary, IL 60013. Product Code 6671

Batch or Lot Expiration Information

Lot# Product Code: 6671; Lots: 51716, EXP 08/22/2017; 52904, EXP 11/07/2017; 53686, EXP 01/03/2018; 54601, 54617, EXP 03/06/2018; 55377, EXP 04/24/2018; 56658, 07/17/2018; 57927, EXP 09/25/2018; 58936, EXP 11/06/2018; 59805, EXP 01/08/2019; 60691, EXP 03/05/2019; 61141, EXP 03/26/2019.

Recall Number: D-0351-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
1680 KITS

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6464 UPC 6 18029 83077 7

Batch or Lot Expiration Information

Lot# Product Code: 6464; Lots: 55175 EXP 8/28/2017; 57086, 58011, EXP 11/13/2017; 58604, EXP 4/3/2018; 60373, EXP 8/2/2018; 60590, EXP 9/4/2018; 61540, EXP 10/16/2018.

Recall Number: D-0376-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
5,579 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free mouthwash, 4 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6422 UPC 6 18029 83031 9

Batch or Lot Expiration Information

Lot# Product Code: 6422; Lots: 57496, 57555, EXP 08/14/2017; 58045, EXP 09/11/2017; 58972, EXP 11/03/2017; 59162EXP 11/13/2017; 59835, EXP 01/02/2018; 60309, EXP 02/05/2018; 61188, EXP 02/23/2018

Recall Number: D-0370-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
887 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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. Product Code 6173

Batch or Lot Expiration Information

Lot# Product Code: 6173; Lots: 57899, EXP 09/19/2017; 58919, EXP 11/15/2017; 60058, EXP 01/08/2018; 61135, EXP 03/05/2018.

Recall Number: D-0353-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
38,792 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Product Code: 6512; Lots: 51381, EXP 8/8/2017; 51433, 51453, EXP 8/15/2017; 51931, EXP 9/12/17; 52754 EXP 10/31/2017; 53326, EXP 11/28/2017; 53826, EXP 1/9/2018; 54266, EXP /15/2018; 54606, EXP 3/6/2018; 54872, EXP 3/21/2018; 55310, 55319, EXP 4/17/2018; 55823, EXP 5/22/2018; 56030, EXP 6/5/2018; 56039, EXP 5/30/2018; 56054, EXP 6/5/2018; 56385, 56408, 56417, EXP 6/26/2018; 56424, 56432, 56440, 56450, EXP 7/5/2018; 56828, EXP 7/27/2018; 57436, EXP 8/29/2018; 57860, EXP 9/25/2018; 58010, EXP 10/2/2018; 58126, EXP 10/9/2018; 58753 EXP 11/6/2018; 59089, 59129, 59143, EXP 11/13/2018; 59762, EXP 1/2/2019; 60261, 60308, EXP 1/22/2019; 60957, EXP 3/12/2019; 61411 EXP 4/9/2019; 61715, EXP 4/23/2019.

Recall Number: D-0359-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
835 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6001-D NDC: 53462-024-30

Batch or Lot Expiration Information

Lot# Product Code: 6001-D; Lots: 52414, 53322, EXP 09/21/2017; 53336, EXP 12/02/2017; 53673, EXP 12/06/2017; 54438, EXP 01/19/2018; 54932, EXP 03/08/2018; 55506, EXP 04/25/2018; 2015323-01, EXP 09/21/2017

Recall Number: D-0394-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
2017 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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, Applicator Swab and 2g Mouth Moisturizer, 2 8 French Oropharyngeal Suction Catheter. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6714 UPC 6 18029 83038 8

Batch or Lot Expiration Information

Lot# Product Code: 6714; Lots: 57979, EXP 09/19/2017; 58845, EXP 10/09/2017; 60215, EXP 01/08/2018; 61235, EXP 03/05/2018.

Recall Number: D-0392-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
672 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Code 6673

Batch or Lot Expiration Information

Lot# Product Code: 6673; Lots: 57938, EXP 09/19/2017; 59802, EXP 01/08/2018; 61329, EXP 03/05/2018.

Recall Number: D-0393-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
6726 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Petit Size Suction Toothbrush packages with Antiseptic Oral Rinse, 4 Petit Size Untreated Suction Oral Swab packages with Antiseptic Oral Rinse, 2 8 French Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6704 UPC 6 18029 84123 0

Batch or Lot Expiration Information

Lot# Product Code: 6704; Lots: 58121, EXP 09/19/2017; 58771, EXP 10/09/2017; 59394, EXP 11/15/2017; 59400, EXP 12/15/2017; 60389, EXP 01/08/2018; 60453, 61087, EXP 01/22/2018; 61121, EXP 03/05/2018; 61579, EXP 04/17/2018.

Recall Number: D-0399-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
60 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6912-S UPC 6 18029 83016 6

Batch or Lot Expiration Information

Lot# Product Code: 6912-S; Lots: 54675, EXP 03/06/2018; 60933, EXP 03/12/2019.

Recall Number: D-0408-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
1273 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6994 UPC 6 18029 83094 4

Batch or Lot Expiration Information

Lot# Product Code: 6994; Lots: 58092, EXP 12/11/2017; 60090, EXP 07/30/2018; 60663, EXP 09/06/2018; 61261, EXP 09/11/2018; 61947, EXP 11/12/2018

Recall Number: D-0372-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
2,938 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Product Code: 6308; Lots: 55134, EXP 08/28/2017, 56144, 56521, EXP 09/26/2017; 57495, EXP 11/13/2017; 58716, EXP 04/03/2018; 59486, EXP 06/15/2018; 59504, EXP 07/16/2018; 60426, EXP 08/02/2018; 61665,EXP 10/16/2018; 62033, 62058, EXP 11/12/2018.

Recall Number: D-0387-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
5138 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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, Perox-A-Mint solution and Mouth Moisturizer, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6594 UPC 6 18029 82134 1

Batch or Lot Expiration Information

Lot# Product Code: 6594; Lots: 53018, 53824, EXP 08/08/2017; 53023, EXP 08/31/2017; 53833, EXP 09/30/2017; 53949, EXP 10/03/2017; 54045, EXP 10/31/2017; 55087, 55169, EXP 11/30/2017; 54708, 55699; 55730; 55952; 56028; 56042, EXP 12/31/2017; 56540; 56945; 57345, EXP 02/28/2018; 57632; 57672, EXP 03/31/2018; 58428, EXP 04/30/2018; 58463, 58506, 58539, 58590, EXP 06/30/2018; 59137, 59395, 59442, EXP 07/31/2018; 60244, EXP 08/31/2018; 60709, 60778, EXP 09/30/2018; 61828, EXP 12/31/2018.

Recall Number: D-0352-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
48,003 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Perox-A-Mint Solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013 Product Code 6912 UPC 6 18029 83016 6

Batch or Lot Expiration Information

Lot# Product Code: 6912; Lots: 52736, 52807, 52878, 52994, 53067, 53084, 53137, 53192, EXP 08/31/2017; 53363, 53459, 53695, 53748, 53868, EXP 9/30/2017; 53916, 54003, 54011, 54012, 54015, 54024, 54049, 54057, 54265, 54279, 54293, EXP 10/31/2017; 54487, 54562, 54613, EXP 12/31/2017; 54686, 54703, 54736, 54745, 54748, 54751, 54817, 54979, 55047, EXP 11/30/2017; 55546, 55561, 55580, 55589, 55602, 55615, 55680, 55709, 55718, 55726, 55735, 55740, 55843, 55857, 55868, 55880, 55900, 55960, EXP 12/31/2017; 56348, 56418, 56604, 56670, 56820, 56944, 56975, 57140, 57201, EXP 02/28/2018; 57506, 57579, 57733, 57900, EXP 03/31/2018; 57925, 58229, 58281, EXP 04/30/2018; 58696, 58762, 59044, EXP 6/30/2018; 59456, 59546, EXP 7/31/2018; 59766, 59830, 60293, 60358, EXP 8/31/2018; 60416, 60563, 60623, 60983, EXP 9/30/2018; 61780, 62118, EXP 12/13/2018

Recall Number: D-0348-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
1182 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages and Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution. Manufactured by: Sage Products, LLC., 3909 Three Oaks Road, Cary, IL 60013 Product Code: 6434; UPC 6 18029 83035 7

Batch or Lot Expiration Information

Lot# Product Code: 6434; Lots: 58519, 58536, EXP 10/02/2017; 59366, EXP 11/13/2017; 60250, 60266, EXP 01/02/2018; 60974, EXP 02/23/2018; 61427, EXP 03/30/2018.

Recall Number: D-0385-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
2424 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Three Oaks Road, Cary, IL 60013. Product Code 6592

Batch or Lot Expiration Information

Lot# Product Code: 6592; Lots: 54071, EXP 10/31/2017; 54664, EXP 12/31/2017; 55007, EXP 11/30/2017; 55866, EXP 12/31/2017; 56487, 56516, 57057, EXP 02/28/2018; 58756, 58766, EXP 06/30/2018; 59618, EXP 07/31/2018; 60036, 60346, EXP 08/31/2019.

Recall Number: D-0382-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
6472 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Product Code: 6570; Lots: 51571, EXP 08/15/2017; 52105, EXP 09/19/2017; 53077, EXP 11/14/2017; 54259, EXP 02/06/2018; 55243, 04/10/2018; 56167, EXP 06/12/2018; 56874, EXP 07/31/2018; 57748, EXP 09/18/2018; 59258, EXP 11/20/2018; 60144, EXP 11/27/2018; 61149, EXP 03/26/2019; 62084, EXP 05/14/2019.

Recall Number: D-0374-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
6,200 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Q CARE q2 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, 6 Suction Oral Swab packages with Alcohol-Free mouthwash, 4 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6412 UPC 6 18029 84137 7

Batch or Lot Expiration Information

Lot# Product Code: 6412; Lots: 58432, EXP 10/02/2017; 59402, EXP 11/13/2017; 59864, EXP 01/02/2018; 60799, EXP 01/22/2018; 61115 EXP 02/23/2018; 61557, EXP 03/30/2018.

Recall Number: D-0355-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
966 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Three Oaks Road, Cary, IL 60013. Product Code 6002 UPC (01)00618029820921

Batch or Lot Expiration Information

Lot# Product Code: 6002; Lots: Product Code: 6002; Lots: 52149, EXP 08/04/2017; 52982, EXP 09/21/2017; 53942, 54042, EXP 01/19/2018; 54925, 54952, 54958, 54959, 54962, EXP 03/08/2018; 55872, EXP 04/25/2018; 57449, EXP 08/25/2018; 58381, EXP 09/14/2018; 59302, EXP 09/22/2018; 59765, EXP 11/22/2018; 61788, 61831 EXP 02/14/2019.

Recall Number: D-0384-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
10505 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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, Cary, IL 60013. Product Code 6572

Batch or Lot Expiration Information

Lot# Product Code: 6572; Lots: 52349, 52367, 52370, 52438, EXP 10/03/2017; 52457, 52471, EXP 10/17/2017; 53106, EXP 11/14/2017; 53569, EXP 12/19/2017; 53945, EXP 01/30/2018; 54354, EXP 02/20/2018; 54950, EXP 03/28/2018; 55452, EXP 04/24/2018; 56131, EXP 06/12/2018; 56901, EXP 07/31/2018; 57791, EXP 09/18/2018; 58455, EXP 10/24/2018; 59447, EXP 12/11/2018; 59869, EXP 01/08/2019; 60887, EXP 03/12/2019; 61883, EXP 04/30/2019.

Recall Number: D-0409-2018

Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Initiated
08-22-2017
Reported
02-21-2018
Quantity
4298 Cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77992
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the 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 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9002 UPC 6 18029 83025 8

Batch or Lot Expiration Information

Lot# Product Code: 9002; Lots: 52886, EXP 08/31/2017; 53688, EXP 09/30/2017; 54468, EXP 10/31/217; 55221, 55230, EXP 11/30/2017; 56320, EXP 2/28/2018; 57367, 58083, EXP 04/30/2018; 58969, EXP 06/30/2018; 59906, EXP 08/31/2018; 61138, EXP 12/31/2018; 61881, EXP 12/13/2018