Edge Pharma, LLC
Edge Pharma, LLC appears in FDA public data with 62 recalls, 0 510(k) clearances, 4 FDA inspections, and 2 compliance actions on record. Its most recent recall (D-0403-2022, Class II) was initiated on December 6, 2021.
Summary
- Total Recalls
- 62
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0403-2022 | Class II | Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe | December 6, 2021 |
| D-0419-2022 | Class II | Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, | December 6, 2021 |
| D-0405-2022 | Class II | Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per | December 6, 2021 |
| D-0418-2022 | Class II | PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV | December 6, 2021 |
| D-0430-2022 | Class II | Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose V | December 6, 2021 |
| D-0448-2022 | Class II | Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe | December 6, 2021 |
| D-0427-2022 | Class II | Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injectio | December 6, 2021 |
| D-0395-2022 | Class II | Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe | December 6, 2021 |
| D-0432-2022 | Class II | CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B O | December 6, 2021 |
| D-0413-2022 | Class II | Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injec | December 6, 2021 |
| D-0443-2022 | Class II | Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules | December 6, 2021 |
| D-0399-2022 | Class II | Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL | December 6, 2021 |
| D-0416-2022 | Class II | Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge | December 6, 2021 |
| D-0440-2022 | Class II | Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermi | December 6, 2021 |
| D-0449-2022 | Class II | Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, S | December 6, 2021 |
| D-0400-2022 | Class II | Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Dropt | December 6, 2021 |
| D-0446-2022 | Class II | Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Top | December 6, 2021 |
| D-0410-2022 | Class II | Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0 | December 6, 2021 |
| D-0398-2022 | Class II | Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 | December 6, 2021 |
| D-0420-2022 | Class II | Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dos | December 6, 2021 |