D-0536-2025 Class III
FDA drug recall D-0536-2025 was initiated by Imprimis NJOF, LLC on July 9, 2025 and is designated Class III. Reason for recall: Sub-Potent Drug: Subpotent assay results during stability testing. Affected quantity: 2,890 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 30, 2025
- Initiation Date
- July 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,890 vials
Product Description
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
Reason for Recall
Sub-Potent Drug: Subpotent assay results during stability testing.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 25MAR032, Exp. 07/16/2025.