Edge Pharma, LLC

FDA Regulatory Profile

Summary

Total Recalls
62
510(k) Clearances
0
Inspections
4
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0412-2022Class IIMVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 December 6, 2021
D-0430-2022Class IICantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose VDecember 6, 2021
D-0403-2022Class IIGemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringeDecember 6, 2021
D-0448-2022Class IIVancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe December 6, 2021
D-0419-2022Class IIPhenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, December 6, 2021
D-0405-2022Class IIMethacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL perDecember 6, 2021
D-0432-2022Class IICSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B ODecember 6, 2021
D-0421-2022Class IIPhenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0December 6, 2021
D-0429-2022Class IICantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge PDecember 6, 2021
D-0442-2022Class IIProfound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / December 6, 2021
D-0441-2022Class IIProfound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% /December 6, 2021
D-0426-2022Class IIVancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV InjectDecember 6, 2021
D-0413-2022Class IIPhenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural InjecDecember 6, 2021
D-0416-2022Class IIPhenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, EdgeDecember 6, 2021
D-0443-2022Class IIPhenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 HerculesDecember 6, 2021
D-0440-2022Class IIProfound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-PeppermiDecember 6, 2021
D-0399-2022Class IIDexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mLDecember 6, 2021
D-0431-2022Class IICSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mgDecember 6, 2021
D-0409-2022Class IIMitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syDecember 6, 2021
D-0423-2022Class IIBetadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, SiDecember 6, 2021