FDA Recalls Fluorescein Sodium Ophthalmic Strips for Manufacturing Defect
The FDA is recalling FUL-GLO Fluorescein Sodium Sterile Ophthalmic Strips (4,648 cartons) nationwide due to unspecified impurities in the active ingredient exceeding USP standards.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with manufacturing defect involving unspecified impurities in the active pharmaceutical ingredient. Ophthalmic products are applied directly to sensitive eye tissues, constituting a risk-of-harm product. No reported illnesses or injuries per source. Meets rubric criterion: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The FDA is recalling FUL-GLO Fluorescein Sodium Sterile Ophthalmic Strips USP, 0.6 mg fluorescein per strip, distributed nationwide. The recall affects 4,648 cartons with lot number 14842 and an expiration date of June 30, 2024.
The recall was initiated because the active pharmaceutical ingredient (API) does not meet current United States Pharmacopeia (USP) monograph standards. The API was manufactured with unspecified impurities that exceed acceptable limits.
Healthcare providers and patients who have received or used this product should consult with their healthcare provider regarding whether they should continue use or switch to an alternative product. For more information, contact your healthcare provider or the FDA.
The recalled product
- 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.
- Manufacturer
- Nomax Inc
- Category
- Drug — Ophthalmic
- Hazard
- unspecified-impurities
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 14842
- Exp. 6/30/2024
Distribution
Distributed nationwide across the United States.
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