D-0489-2017 Class III Terminated
FDA drug recall D-0489-2017 was initiated by Sage Products Inc on February 2, 2017 and is designated Class III. 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 … The recall status is terminated (terminated August 28, 2018). Affected quantity: 640 kits.
Recall Details
- Product Type
- Drugs
- Report Date
- March 1, 2017
- Initiation Date
- February 2, 2017
- Termination Date
- August 28, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
Code Information
Lot 59123, Exp 11/13/17