Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4....
FDA Drug Recall #D-0400-2018 — Class II — August 22, 2017
Recall Summary
| Recall Number | D-0400-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 22, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Sage Products Inc |
| Location | Cary, IL |
| Product Type | Drugs |
| Quantity | 82072 Cases |
Product Description
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
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
Distribution Pattern
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Lot / Code Information
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
Other Recalls from Sage Products Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0382-2018 | Class II | Toothette Oral Care Suction Toothbrushes with P... | Aug 22, 2017 |
| D-0409-2018 | Class II | Q Care RX Oral Cleansing & Suctioning System wi... | Aug 22, 2017 |
| D-0353-2018 | Class II | Toothette Suction Toothbrush with Perox-A-Mint ... | Aug 22, 2017 |
| D-0360-2018 | Class II | Toothette Oral Care Short-Term Oral Swab System... | Aug 22, 2017 |
| D-0370-2018 | Class II | Toothette Oral Care Suction Toothbrushes with A... | Aug 22, 2017 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.