The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0387-2021·Announced 2021-05-26

Nomax Recalls Subpotent Dry Eye Test Fluorescein Sodium Strips

Nomax Inc. is voluntarily recalling 78 cartons of Dry Eye Test strips due to subpotent drug content. The FDA classified this as a Class III recall.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Nomax Inc. is voluntarily recalling 78 cartons of Dry Eye Test (Fluorescein Sodium) Ophthalmic Strips. The product is identified by NDC 51801-008-15, Lot 13336, and an expiration date of 07/23. Each carton contains 100 sterile strips packaged in 50 pouches of 2 strips each.

The recall was initiated because the product was found to be a subpotent drug, meaning it did not contain the full amount of the active ingredient as labeled. The FDA classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

The affected product was distributed nationwide in the United States. The recall was initiated on April 13, 2021, and was terminated on September 28, 2023. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above.

The recalled product

Product
DRY EYE TEST (FLUORESCEIN SODIUM)
Brand
DRY EYE TEST
Manufacturer
Nomax Inc
Category
Drug — Ophthalmic
Hazard
Affected units
78

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • LOT 13336 EXP 07/23

Distribution

Distributed nationwide across the United States.

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