FDA Recall D-0131-2024
Cardinal Health Inc. · Dublin, OH
Class I — life-threatening Ongoing 926 days on record
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 record
- Recall number
D-0131-2024- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-10-31
- Classified by FDA Center
- 2023-12-01
- FDA published
- 2023-11-29
- Recalling firm
- Cardinal Health Inc.
- Firm location
- Dublin, OH
Drug identification
- Brand name(s)
- EYES IRRITATION RELIEF
- Generic name(s)
- POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE
- Manufacturer(s)
- CARDINAL HEALTH 110, LLC. DBA LEADER
- NDC(s)
70000-0087- Route(s)
- OPHTHALMIC
Operational response
A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.
For the official FDA enforcement record, see FDA's Recall Search.