Class III
Ongoing
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.
This recall is currently active, issued July 30, 2025. It was issued by Imprimis Njof, Llc.
- Company
- Imprimis Njof, Llc
- Recall Initiated
- July 9, 2025
- Posted
- July 30, 2025
- Recall Number
- D-0536-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,890 vials
- Firm Location
- Ledgewood, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Sub-Potent Drug: Subpotent assay results during stability testing.
Distribution
Nationwide in the USA
Lot / Code Info
Lot: 25MAR032, Exp. 07/16/2025.
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