FDAFDA · Food and drugs·Recall number D-0465-2024
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.
Published May 1, 2024 · Recall initiated: April 19, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Nomax Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 14776, Exp. 05/31/2024.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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