Status
Ongoing
Drug Enforcement D-0463-2024
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.
Classification
Class II
Report Date
May 1, 2024
Termination Date
—
Product Information
- 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.
- 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.
- Recall initiation reason
- —
- Initial firm notification
- N/A
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Nomax Inc
- Address
-
9735 Green Park Industrial Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0463-2024
- Event ID
- 94461
- Recall initiation date
- April 19, 2024
- Center classification date
- April 23, 2024
- Code info
- Lot #: 14708, Exp. 04/30/2024.
- More code info
- —