GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Ste… recall

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 (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40.

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