D-0135-2024 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 29, 2023
- Initiation Date
- October 31, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,782 bottles
Product Description
LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1
Reason for Recall
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution Pattern
Nationwide in the USA
Code Information
ALL LOTS