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.
Reported: May 1, 2024 Initiated: April 19, 2024 #D-0465-2024
Product 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.
Reason for Recall
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.
Details
- Recalling Firm
- Nomax Inc
- Units Affected
- 15,444 cartons
- Distribution
- Nationwide in the USA
- Location
- Saint Louis, MO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Nomax Inc. Units affected: 15,444 cartons.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 1, 2024. Severity: Moderate. Recall number: D-0465-2024.
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