D-0298-2024 Class I Ongoing
FDA drug recall D-0298-2024 was initiated by Kilitch Healthcare India Limited on November 13, 2023 and is designated Class I. Reason for recall: Non-Sterility The recall status is ongoing. Affected quantity: 150,720 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 14, 2024
- Initiation Date
- November 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150,720 bottles
Product Description
CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
Reason for Recall
Non-Sterility
Distribution Pattern
Nationwide within the United States
Code Information
All lots