Fluorescein Sodium Strips (Nomax) – Dosage Uniformity (2015)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode (01)00317478404019; packaged in 100-count strips per carton, (NDC 17478-404-01), UPC 3 17478 40401 9, Manufactured for: Akorn, Inc., Lake Forest, IL 60045.; and 2)Fluorescein Pro Glo Strips, individually wrapped strips, barcode (01)00360843000026, packaged in 300-count strips per carton, (NDC 60843-300-50), UPC 3 60843 30050 8, Manufactured for Eye Care and Cure by Nomax, Inc.,
Brand
Nomax Inc
Lot Codes / Batch Numbers
1) FUL-GLO Lot: 8980, Exp 10/15, 9081, Exp 01/16, 9088, Exp 02/16, 9128 and 9158, Exp 03/16, 2) Pro Glo Lot: 9082, Exp 01/17
Products Sold
1) FUL-GLO Lot: 8980, Exp 10/15; 9081, Exp 01/16; 9088, Exp 02/16; 9128 and 9158, Exp 03/16; 2) Pro Glo Lot: 9082, Exp 01/17
Nomax Inc is recalling Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrap due to Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026