Dry Eye Test Strip
FDA Recall NDC 51801-008
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Dry Eye Test (NDC 51801-008). A significant event, classified as Class III, was initiated on Apr 13, 2021 by Nomax Inc.. The reported reason for this action was: "Subpotent Drug"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug
Apr 13, 2021
May 26, 2021
78 cartons
Recall Profile & Regulatory Data
Event ID
87695
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Nomax Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 28, 2023
Product Description
Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15
Batch or Lot Expiration Information
Lot# LOT 13336 EXP 07/23
Affected Packages Involved in this Recall
51801-008-15Product
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.
