Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
Lot 59123, Exp 11/13/17
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0489-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 2, 2017
- FDA report date
- Mar 1, 2017
- Quantity
- 640 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sage Products Inc
Original FDA data
Every field from FDA enforcement report D-0489-2017, exactly as published.
Show all FDA fields
- City
- Cary
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 76424
- Address
- 3909 3 Oaks Rd
- Code information
- Lot 59123, Exp 11/13/17
- Postal code
- 60013-1804
- Report date
- Mar 1, 2017
- Product type
- Drugs
- Recall number
- D-0489-2017
- Classification
- Class III
- Recalling firm
- Sage Products Inc
- Product quantity
- 640 kits
- Termination date
- Aug 28, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 2, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 21, 2017