Edge Pharma, LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
D-0423-2022Class IIBetadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, SiDecember 6, 2021
D-0430-2022Class IICantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose VDecember 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-0427-2022Class IIVancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV InjectioDecember 6, 2021
D-0414-2022Class IIPhenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/December 6, 2021
D-0411-2022Class IINeostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM InjDecember 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-0412-2022Class IIMVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 December 6, 2021
D-0403-2022Class IIGemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringeDecember 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-0418-2022Class IIPHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IVDecember 6, 2021
D-0447-2022Class IITetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, EdDecember 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-0433-2022Class IIDexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, EdgDecember 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-0417-2022Class IIPhenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use SyringDecember 6, 2021