Status
Ongoing
Drug Enforcement D-0131-2024
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Classification
Class I
Report Date
November 29, 2023
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 11629 units
- Reason for recall
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Cardinal Health Inc.
- Address
-
7000 Cardinal Pl, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0131-2024
- Event ID
- 93346
- Recall initiation date
- October 31, 2023
- Center classification date
- December 1, 2023
- Code info
- ALL LOTS
- More code info
- —