D-0293-2024 Class I Ongoing
FDA drug recall D-0293-2024 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: 1,492,344 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
- 1,492,344 bottles
Product Description
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
Reason for Recall
Non-Sterility
Distribution Pattern
Nationwide within the United States
Code Information
All lots