LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL
Summary
The FDA issued a Class I for LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetra by Cardinal Health Inc.. Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility..
Details
Source
Drug Recall
External ID
D-0131-2024
Action Date
2023-11-29
Status
Ongoing
Category
drug
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
Lot/Code Info: ALL LOTS
Quantity Affected: 11629 units
Reason for Recall
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-31
Company
Dublin, OH
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 38 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Cardinal Health Inc. has 14 FDA actions in our database, including 14 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health Inc. have FDA actions?
Cardinal Health Inc. has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0131-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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