Home / Recalls / Imprimis NJOF, LLC / D-0536-2025

D-0536-2025 Class III Ongoing

Recalled by Imprimis NJOF, LLC — Ledgewood, NJ

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.

Other recalls by Imprimis NJOF, LLC

  • D-0249-2026 Class II — Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, R (December 18, 2025)
  • D-0250-2026 Class II — Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Us (December 18, 2025)
  • D-0251-2026 Class II — Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use In (December 18, 2025)
  • D-0157-2026 Class III — Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsi (October 20, 2025)
  • D-0535-2025 Class II — Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx (July 9, 2025)
  • D-0305-2025 Class III — Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Soluti (February 24, 2025)
  • D-0516-2024 Class II — Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocula (May 14, 2024)
  • D-0519-2024 Class II — Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single- (May 14, 2024)
  • D-0547-2024 Class II — Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5m (May 14, 2024)
  • D-0514-2024 Class II — Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preserv (May 14, 2024)