RecallCheckr

Edge Pharma, LLC recalls

30 recalls on record · FDA

Every recall we have on record for Edge Pharma, LLC, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.

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Health Serious

Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single…

Lack of Assurance of Sterility.

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC,…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% /…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free,…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial,…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution,…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl,…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free,…

Lack of Assurance of Sterility

Edge Pharma, LLC Feb 2, 2022
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Health Serious

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%,…

CGMP Deviations

Edge Pharma, LLC Feb 2, 2022
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