FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 steril… recall

Why it was recalled

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.

Details

Product

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.

Recalling company

Nomax Inc

Classification

Class II

Status

Ongoing

Type

Voluntary: Firm initiated

Distribution

Nationwide in the USA

Initiated

Apr 19, 2024

FDA report date

May 1, 2024