FDA Drug Recalls

Recalls / Firms / Edge Pharma, LLC

Edge Pharma, LLC

62 FDA drug recalls on record.

DateClassDrugStatus
2021-12-06Class IIPromethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose SyreinTerminated
2021-12-06Class IIPhenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, MuTerminated
2021-12-06Class IIPhenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV InjTerminated
2021-12-06Class IILT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Terminated
2021-12-06Class IILidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose CoTerminated
2021-12-06Class IIMVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mgTerminated
2021-12-06Class IIGemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL pTerminated
2021-12-06Class IIPhenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free,Terminated
2021-12-06Class IIMethacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free,Terminated
2021-12-06Class IIPHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use Terminated
2021-12-06Class IITetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for IntranasTerminated
2021-12-06Class IIBetadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per sTerminated
2021-12-06Class IICantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, MultiTerminated
2021-12-06Class IIVancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single DosTerminated
2021-12-06Class IIPhenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 1Terminated
2021-12-06Class IIVancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for ITerminated
2021-12-06Class IIPhenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10Terminated
2021-12-06Class IILidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single UsTerminated
2021-12-06Class IINeostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IVTerminated
2021-12-06Class IICSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/AmphotTerminated
2021-12-06Class IIPhenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.Terminated
2021-12-06Class IICantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical UTerminated
2021-12-06Class IIProfound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 1Terminated
2021-12-06Class IIProfound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 1Terminated
2021-12-06Class IIVancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag forTerminated
2021-12-06Class IIDexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For TopicaTerminated
2021-12-06Class IIPhenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for PerineTerminated
2021-12-06Class IIPhenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 85Terminated
2021-12-06Class IIDexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.Terminated
2021-12-06Class IICSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic PoTerminated
2021-12-06Class IIPhenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV InjecTerminated
2021-12-06Class IIProfound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, SpearminTerminated
2021-12-06Class IITrypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection PreservatiTerminated
2021-12-06Class IIVancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag foTerminated
2021-12-06Class IIEdetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single DoTerminated
2021-12-06Class IILET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syTerminated
2021-12-06Class IILidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 Terminated
2021-12-06Class IIALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 Terminated
2021-12-06Class IIEpinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.Terminated
2021-12-06Class IIVitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe fTerminated
2021-12-06Class IILidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic STerminated
2021-12-06Class IIDibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge PTerminated
2021-12-06Class IIMitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8Terminated
2021-12-06Class IIMitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical UTerminated
2021-12-06Class IIVancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (Terminated
2021-12-06Class IICeftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mLTerminated
2021-12-06Class IIEdetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Terminated
2021-12-06Class IIDibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Terminated
2021-12-06Class IIMoxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (Terminated
2021-12-06Class IICefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mgTerminated
2021-12-06Class IIMethotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syriTerminated
2021-12-06Class IIBLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple DoseTerminated
2021-12-06Class IIMitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mTerminated
2021-12-06Class IILidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Terminated
2021-12-06Class IIProfound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry MarTerminated
2021-12-06Class IIPhenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Terminated
2021-04-12Class IIBetadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical OTerminated
2021-02-17Class IIIMethacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative FreeTerminated
2020-12-22Class IIIEpinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Terminated
2020-07-02Class IIVancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1Terminated
2020-03-19Class IICeftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (2Terminated
2020-03-19Class IIMethotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5Terminated
Edge Pharma, LLC — FDA drug recalls (62) · FDA Drug Recalls