FDA Recall D-0464-2024

Nomax Inc · Saint Louis, MO

Class II Ongoing 755 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot 14842, Exp. 6/30/2024

Quantity: 4648 cartons

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.

Recall record

Recall number: D-0464-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Nationwide in the USA
Recall initiated: 2024-04-19
Classified by FDA Center: 2024-04-23
FDA published: 2024-05-01
Recalling firm: Nomax Inc
Firm location: Saint Louis, MO

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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