Class IIOngoing

GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100… recall

FDA recall D-0462-2024 · initiated Apr 19, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was 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.

Details

Product: GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.
Recalling company: Nomax Inc
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Apr 19, 2024
FDA report date: May 1, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0462-2024 ↗

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