Nomax Inc: Drug Recall

Recall #D-0463-2024 · 04/19/2024

Class II: Risk

Recall Details

Recall Number
D-0463-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Nomax Inc
Status
Ongoing
Date Initiated
04/19/2024
Location
Saint Louis, MO, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,960 cartons

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.

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.

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.