← Every firm
Imprimis NJOF, LLC FDA Recalls
20 recalls on file across drugs, 0 of them Class I and 15 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, Class IIDec 18, 2025Presence of particulate matter - Glass like particles. |
| Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NClass IIDec 18, 2025Presence of particulate matter - Glass like particles. |
| Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC.Class IIDec 18, 2025Presence of particulate matter - Glass like particles. |
| Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office UsClass IIIOct 20, 2025Subpotent Drug |
| Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per caClass IIIJul 9, 2025Sub-Potent Drug: Subpotent assay results during stability te |
| Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 WesClass IIJul 9, 2025Sub-Potent Drug: Subpotent assay results during stability te |
| Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15Class IIIFeb 24, 2025Sub-Potent Drug: The stability batch showed a subpotent resu |
| Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx onClass IIMay 14, 2024Lack of Assurance of Sterility |
| Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, ImpClass IIMay 14, 2024Lack of Assurance of Sterility |
| Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NClass IIMay 14, 2024Lack of Assurance of Sterility |
| Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, CompoClass IIMay 14, 2024Lack of Assurance of Sterility |
| Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LClass IIMay 14, 2024Lack of Assurance of Sterility |
| Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for IntClass IIMay 14, 2024Lack of Assurance of Sterility |
| Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, ImprClass IIMay 14, 2024Lack of Assurance of Sterility |
| Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLCClass IIMay 14, 2024Lack of Assurance of Sterility |
| Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLClass IIIApr 10, 2024Out of specification for assay |
| Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: IClass IIApr 10, 2024Subpotent Drug |
| Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-Class IIIOct 3, 2023Subpotent: Failing Test Results for Epinephrine |
| MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% -Class IIISep 20, 2023Subpotent: Out of Specification result observed for Ketorola |
| Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Class IIIAug 10, 2023Subpotent Drug; sub-potent Bromfenac levels, below the 90.0- |