FDA recall D-0297-2024

Product

Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1

Reason for recall

Non-Sterility

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2023-11-13

Report date

2024-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Navi Mumbai, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0297-2024