REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Nomax Inc.'s Fluorescein Sodium Ophthalmic Strips Fail USP Impurity Specifications
Nomax Inc. has initiated a Class II recall (D-0462-2024) for 15,056 cartons of GLOSTRIPS, Fluorescein Sodium Ophthalmic Strips, due to active pharmaceutical ingredient (API) non-compliance with USP monograph specifications for unspecified impurities. This voluntary nationwide recall highlights critical quality control failures in API manufacturing, posing immediate supply chain risks for ophthalmic diagnostic products and underscoring the need for rigorous supplier qualification.
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