FDA-Drug2024-02-14Class I

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

Kilitch Healthcare India Limited
Hazard

Non-Sterility

Sold states
Nationwide within the United States
Affected count
10,944 bottles
Manufactured in
R - 904 905 T T C Industrial Road, Navi Mumbai, India
Products
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

Official notice

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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief