Edge Pharma recalls

Edge Pharma appears in 62 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercul…
  FDA Drug · Class II · 2022-02-02 · Edge Pharma
  Reason: Lack of Assurance of Sterility
• Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
  FDA Drug · Class II · 2022-02-02 · Edge Pharma
  Reason: CGMP Deviations
• Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LL…
  FDA Drug · Class II · 2022-02-02 · Edge Pharma
  Reason: CGMP Deviations
• Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe F…
  FDA Drug · Class II · 2022-02-02 · Edge Pharma
  Reason: Lack of Assurance of Sterility
• Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colch…
  FDA Drug · Class II · 2022-02-02 · Edge Pharma
  Reason: CGMP Deviations
• Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchest…
  FDA Drug · Class II · 2022-02-02 · Edge Pharma
  Reason: Lack of Assurance of Sterility
• Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC…
  FDA Drug · Class II · 2021-04-28 · Edge Pharma
  Reason: Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
• Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercule…
  FDA Drug · Class III · 2021-03-24 · Edge Pharma
  Reason: Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
• Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge P…
  FDA Drug · Class III · 2021-03-24 · Edge Pharma
  Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
• Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe
  FDA Drug · Class II · 2021-01-27 · Edge Pharma
  Reason: Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
• Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTIO…
  FDA Drug · Class II · 2021-01-20 · Edge Pharma
  Reason: Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
• Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01
  FDA Drug · Class II · 2020-09-16 · Edge Pharma
  Reason: Labeling: Label Error on Declared Strength