D-0463-2024 Class II Ongoing

Recalled by Nomax Inc — Saint Louis, MO

Recall Details

Product Type
Drugs
Report Date
May 1, 2024
Initiation Date
April 19, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,960 cartons

Product Description

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.

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 14708, Exp. 04/30/2024.