Ophthalmic Strips Pulled for Potential Impurities

Nomax Inc. is recalling more than 42,000 cartons of GloStrips and Ful-Glo fluorescein sodium ophthalmic strips because the active pharmaceutical ingredient used in the products failed to meet impurity specifications, according to the May 1, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were distributed throughout the United States:

• GloStrips fluorescein sodium ophthalmic strips (0.6 mg fluorescein), 100 strips per carton (NDC 51801-003-40), from lots 14904 (Exp. 6/30/24) and 14938 (Exp. 7/31/24);
• GloStrips fluorescein sodium ophthalmic strips (0.6 mg fluorescein), 300 strips per carton (NDC 51801-003-50), from lot 14931 (Exp. 6/30/24); 
• GloStrips fluorescein sodium ophthalmic strips (1 mg fluorescein), 100 sterile strips per carton (NDC 51801-009-40), from lot 14708 (Exp. 4/30/24);
• Ful-Glo fluorescein sodium sterile ophthalmic strips (0.6 mg fluorescein), 300 sterile strips per carton, manufactured for Akorn Inc., Lake Forest, Illinois (NDC 17478-403-03), from lot 14842 (Exp. 6/30/24); and 
• Ful-Glo fluorescein sodium ophthalmic strips (1 mg), 100 sterile strips per carton, manufactured for Akorn Inc., Lake Forest, Illinois (NDC 17478-404-01), from lot 14776 (Exp. 5/31/24).

Nomax voluntarily initiated the recalls on April 19, 2024. On April 23, 2024, the FDA designated them Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

GloStrips and Ful-Glo fluorescein sodium ophthalmic strips are diagnostic agents for professional use. They are indicated for staining the anterior segment of the eye in disclosing corneal injury, in applanation tonometry, and when fitting contact lenses.