FUL-GLO Fluorescein Sodium Ophthalmic Strips Recalled for API Manufacturing Defect
Nomax Inc recalls FUL-GLO Fluorescein Sodium Ophthalmic Strips (Lot 14776) nationwide due to API manufacturing specification failures. The active ingredient was not manufactured to current USP standards regarding unspecified impurities.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard involves unspecified impurities in the API due to manufacturing specification failure—a theoretical risk requiring precautionary action but without documented patient harm.
Plain-English summary
FUL-GLO Fluorescein Sodium Ophthalmic Strips USP 1 mg (Lot 14776, expiration 05/31/2024) are being recalled nationwide by Nomax Inc for Akorn, Inc., Lake Forest, Illinois.
The recall is due to a manufacturing quality control issue: the active pharmaceutical ingredient (API) was not manufactured to current United States Pharmacopeia (USP) standards regarding unspecified impurities.
Patients and healthcare providers using FUL-GLO strips from Lot 14776 should stop using the product. Cartons can be identified by lot number 14776 and expiration date 05/31/2024. Contact Nomax Inc or Akorn, Inc. for return or replacement instructions.
The recalled product
- Product
- FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.
- Manufacturer
- Nomax Inc
- Category
- Drug — Ophthalmic
- Affected units
- 15,444
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 (2)
- Lot #: 14776
- Exp. 05/31/2024.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Nomax Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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