Eyes Irritation Relief Liquid
FDA Recall NDC 70000-0087
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Eyes Irritation Relief (NDC 70000-0087). A significant event, classified as Class I, was initiated on Nov 13, 2023 by Cardinal Health 110, Llc. Dba Leader. The reported reason for this action was: "Non-Sterility"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Non-Sterility
Nov 13, 2023
Feb 14, 2024
10,944 bottles
Recall Profile & Regulatory Data
Event ID
93357
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Kilitch Healthcare India Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
Lot# All lots
Affected Packages Involved in this Recall
70000-0087-1Product
Class I Ongoing
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Oct 31, 2023
Nov 29, 2023
11629 units
Recall Profile & Regulatory Data
Event ID
93346
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# ALL LOTS
Affected Packages Involved in this Recall
70000-0087-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
