Edge Pharma, LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
D-0434-2022Class IIDibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLDecember 6, 2021
D-0420-2022Class IIPhenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple DosDecember 6, 2021
D-0415-2022Class IIPhenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, EdDecember 6, 2021
D-0436-2022Class IILT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical UsDecember 6, 2021
D-0444-2022Class IILidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, EDecember 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-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-0422-2022Class IIPhenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/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-0395-2022Class IILidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe 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-0432-2022Class IICSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B ODecember 6, 2021