D-0294-2024 Class I Ongoing
FDA drug recall D-0294-2024 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: 110,832 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
- 110,832 bottles
Product Description
CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10
Reason for Recall
Non-Sterility
Distribution Pattern
Nationwide within the United States
Code Information
All lots