FDA-Drug2024-05-01Class II

FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.

Nomax Inc
Hazard

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Sold states
Nationwide in the USA
Affected count
4648 cartons
Manufactured in
9735 Green Park Industrial Dr, N/A, Saint Louis, MO, United States
Products
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0464-2024

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