Home / Recalls / Imprimis NJOF, LLC / D-0478-2024

D-0478-2024 Class III Ongoing

Recalled by Imprimis NJOF, LLC — Ledgewood, NJ

Recall Details

Product Type
Drugs
Report Date
May 8, 2024
Initiation Date
April 10, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,414 units

Product Description

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01

Reason for Recall

Out of specification for assay

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024

Other recalls by Imprimis NJOF, LLC

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  • D-0249-2026 Class II — Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, R (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-0536-2025 Class III — Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1 (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)