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
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
Failed Impurities/Degradation Specifications