Recall D-0465-2024
Description: FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.
Recall D-0465-2024 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0465-2024 |
Event ID | 94461 |
Distribution | Nationwide in the USA |
Quantity | 15,444 cartons |
Recall 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. |
Drug Classification | Class II |
Drug Code Info | 20240501 |
Recall Initiation Date | 20240419 |
Report Date | 20240501 |
Classification Date | 20240423 |
Address | 9735 Green Park Industrial Dr Saint Louis, MO 63123-7241 United States |
Recalling Firm | Nomax Inc |
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