D-0463-2024 Class II Ongoing
FDA drug recall D-0463-2024 was initiated by Nomax Inc on April 19, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 6,960 cartons.
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.