CFAI
C.F.A.I.
Government Data Intelligence Services

Edge Pharma, LLC

Company VT
Found in 2 federal databases · 63 total records
fda 62 records
FDA Drug Recall: Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per droppe 2022-02-02
Class II — Lack of Assurance of Sterility.
View Source
FDA Drug Recall: Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.1 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharm 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrin 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per v 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Dexamethasone sodium phosphate, sterile otic solution for injection Preservative 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe fo 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single D 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per v 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:1 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Mul 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preserva 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vi 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8m 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic S 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenyleph 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Ras 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single U 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservativ 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4% 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic So 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syri 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0. 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortis 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 m 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per d 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intr 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic So 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preserva 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Op 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), S 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Cont 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multip 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 m 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container fo 2022-02-02
Class II — CGMP Deviations
View Source
FDA Drug Recall: Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL 2022-02-02
Class II — Lack of Assurance of Sterility
View Source
FDA Drug Recall: Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For 2021-04-28
Class II — Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
View Source
FDA Drug Recall: Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preserv 2021-03-24
Class III — Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
View Source
FDA Drug Recall: Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per 2021-03-24
Class III — Labeling: Incorrect or Missing Lot and/or Exp Date
View Source
FDA Drug Recall: Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg 2021-01-27
Class II — Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
View Source
FDA Drug Recall: Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (2 2021-01-20
Class II — Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
View Source
FDA Drug Recall: Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 N 2020-09-16
Class II — Labeling: Label Error on Declared Strength
View Source
ny_corps 1 records
NY Corp: EDGE PHARMA, LLC 2014-07-11
FOREIGN LIMITED LIABILITY COMPANY | County: Erie | Jurisdiction: Delaware
View Source
Be informed when major changes happen on C.F.A.I. — new data sources, platform updates, critical enforcement alerts
No spam. Only major updates. Unsubscribe anytime.
Search Sources About The Signal Screening Terms Privacy
© 2026 CFAISOLUTIONS LLC · cfai.app · CourtPulse
C.F.A.I. aggregates publicly available federal records for informational purposes only. Nothing on this site constitutes legal, financial, or professional advice. No claims are made regarding the accuracy or completeness of any data presented.