Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Reason Subpotent Drug
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current…
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