Home / Recalls / Imprimis NJOF, LLC / D-0547-2024

D-0547-2024 Class II Ongoing

Recalled by Imprimis NJOF, LLC — Ledgewood, NJ

Recall Details

Product Type
Drugs
Report Date
June 19, 2024
Initiation Date
May 14, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
136,005 units

Product Description

Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

US Nationwide

Code Information

Lot:23APR005 Exp. 5/1/2024 Lot:23MAY024 Exp. 5/15/2024 Lot:23JUN010 Exp. 5/30/2024 Lot:23JUN016 Exp. 6/7/2024 Lot:23JUN047 Exp. 7/4/2024 Lot:23JUL013 Exp. 7/11/2024 Lot:23JUL029 Exp. 7/25/2024 Lot:23JUL030 Exp. 8/1/2024 Lot:23AUG016 Exp. 8/7/2024 Lot:23AUG042 Exp. 9/27/2024 Lot:23SEP017 Exp. 7/13/2024 Lot:23OCT039 Exp. 8/3/2024 Lot:23NOV022 Exp. 8/24/2024 Lot:23NOV036 Exp. 8/29/2024 Lot:23DEC021 Exp. 10/4/2024 Lot:24JAN018 Exp. 10/11/2024 Lot:24JAN026 Exp. 10/24/2024 Lot:24JAN040 Exp. 11/2/2024 Lot:24FEB021 Exp. 11/16/2024 Lot:24MAR005 Exp. 12/12/2024

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-0251-2026 Class II — Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use In (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-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-0513-2024 Class II — Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Us (May 14, 2024)
  • D-0512-2024 Class II — Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single- (May 14, 2024)
  • D-0516-2024 Class II — Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocula (May 14, 2024)