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
Reason for recall: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recall initiated: 20231031
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated