Edge Pharma, LLC Provisional

Colchester, VT · united states

56 recall flag(s)

FDA Flags (56)

Class II RecallFeb 2022
Edge Pharma, LLC
Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Op
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Opht
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syring
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr,
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL p
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 He
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC,
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, Fo
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, L
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Ed
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, S
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syri
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., C
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, S
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, E
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-M
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pha
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Mu
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Fr
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Co
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 H
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per s
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma,
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syring
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Sy
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Top
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, L
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Herc
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Herc
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivale
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preserva
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, F
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC,
Classification: Class II
Class II RecallFeb 2022
Edge Pharma, LLC
Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856
Classification: Class II