Edge Pharma, LLC: 59 recalls on record

Recalls filed with 1 agency: FDA (59).

First recall on record: September 16, 2020. Most recent: February 2, 2022.

Risk classification: Class II: 57 · Class III: 2

Most recent recalls

DateAgencyProduct
February 2, 2022FDAProfound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, …D-0441-2022
February 2, 2022FDABetadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per …D-0423-2022
February 2, 2022FDALET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per s…D-0437-2022
February 2, 2022FDAProfound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmi…D-0440-2022
February 2, 2022FDALidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple…D-0438-2022
February 2, 2022FDAPhenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV In…D-0415-2022
February 2, 2022FDAPhenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 1…D-0414-2022
February 2, 2022FDACefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 m…D-0398-2022
February 2, 2022FDAPhenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free…D-0419-2022
February 2, 2022FDALidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic …D-0404-2022
February 2, 2022FDAVancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag f…D-0425-2022
February 2, 2022FDAProfound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / …D-0442-2022
February 2, 2022FDALidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose C…D-0444-2022
February 2, 2022FDAVancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Do…D-0448-2022
February 2, 2022FDACantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Mult…D-0430-2022
February 2, 2022FDACeftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 m…D-0397-2022
February 2, 2022FDAGemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL …D-0403-2022
February 2, 2022FDAEpinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0…D-0402-2022
February 2, 2022FDACantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical …D-0429-2022
February 2, 2022FDALidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3…D-0396-2022
February 2, 2022FDAProfound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Ma…D-0439-2022
February 2, 2022FDACSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic P…D-0431-2022
February 2, 2022FDAPhenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, …D-0422-2022
February 2, 2022FDATrypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservat…D-0449-2022
February 2, 2022FDAPhenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, M…D-0420-2022

Questions about this company

How many recalls does Edge Pharma, LLC have?
Recalert has 59 U.S. recalls on record for Edge Pharma, LLC, published between September 16, 2020 and February 2, 2022.
What was the most recent Edge Pharma, LLC recall?
FDA recall D-0441-2022, published February 2, 2022: Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856…
Which agencies have handled Edge Pharma, LLC recalls?
Edge Pharma, LLC appears as the recalling firm in recalls from: FDA (59).

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