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Recall Observatory FDA recall evidence

Drug 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.

D-0464-2024

April 19, 2024

Class II

Product summary

Firm
Nomax Inc
Event
Event 94461
Status
Ongoing
Classification
Class II
Quantity
4648 cartons
Official record key
drug-enforcement:D-0464-2024

Official wording

Reason: 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.

Code information: Lot 14842, Exp. 6/30/2024

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications