April 2021 FDA Recall Dry Eye Test by Nomax Inc
D-0387-2021 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Nomax Inc on April 13, 2021 for the product Dry Eye Test. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0387-2021

Reason for Recall
Subpotent Drug
Initiated
04-13-2021
Reported
05-26-2021
Quantity
78 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87695
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Nomax Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2023
Product Description About Product Description
Full technical description of the product.
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

51801-008-15 Dry Eye Test