Drug product
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1
D-0131-2024
Product summary
- Event
- Event 93346
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 11629 units
- Official record key
drug-enforcement:D-0131-2024
Official wording
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Code information: ALL LOTS
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.