Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Sucti...

FDA Drug Recall #D-0489-2017 — Class III — February 2, 2017

Recall Summary

Recall Number D-0489-2017
Classification Class III — Low risk
Date Initiated February 2, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sage Products Inc
Location Cary, IL
Product Type Drugs
Quantity 640 kits

Product Description

Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, Rx only, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013, Reorder #6306, UPC 6 18029 83041 8.

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

Lot 59123, Exp 11/13/17

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

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

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.