D-0462-2024 Class II Ongoing
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
- 15,056 cartons
Product Description
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.
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 #s: a) 14904, Exp. 06/30/2024; Lot 14938, Exp. 07/31/2024; b) Lot 14931, Exp. 06/30/2024