Drug 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.
D-0463-2024
Product summary
- Firm
- Nomax Inc
- Event
- Event 94461
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,960 cartons
- Official record key
drug-enforcement:D-0463-2024
Official wording
Reason: 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.
Code information: Lot #: 14708, Exp. 04/30/2024.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications