Edge Pharma Recalls
62 recalls on record · September 16, 2020 to February 2, 2022 · Drugs
Recalls by year
20
21
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, S
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preserva
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection,
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 He
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per s
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, L
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma,
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, S
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Sy
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syri
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Herc
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Her
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syring
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Opht
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Op
Hazard: Lack of Assurance of Sterility.
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL p
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syring
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single us
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, L
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pha
Hazard: Lack of Assurance of Sterility
April 28, 2021DrugsFDA
Edge Pharma, LLC recalls Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT)
Hazard: Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
March 24, 2021DrugsFDA
Edge Pharma, LLC recalls Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.7
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date
March 24, 2021DrugsFDA
Edge Pharma, LLC recalls Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharm
Hazard: Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
January 27, 2021DrugsFDA
Edge Pharma, LLC recalls Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. K
Hazard: Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.