Edge Pharma, LLC recalls

62 recalls on record · latest: December 6, 2021

Official U.S. recall history for Edge Pharma, LLC, compiled from official government records.

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Edetate Disodium recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility.

Edetate Disodium recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

MVASI recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Phenol recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Profound-PE Dental Gel recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Gemcitabine recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Dibutyl Squaric Acid recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Dexamethasone sodium phosphate recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Phenylephrine HCl recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

LET Topical Gel recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Promethazine HCl Topical Ointment recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Vitamin K Oral Solution recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Betadine recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Cantharidin PLUS recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Lidocaine HCl/Epinephrine recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

BLT Topical Cream recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Phenylephrine HCl/Lidocaine recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Mitomycin-C Sterile Ophthalmic Solution recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Dibutyl Squaric Acid recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Moxifloxacin recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Lidocaine HCl / Oxymetazoline HCl Nasal Solution recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Vancomycin HCl Oral Solution 125mg / recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Edge Pharma product recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Profound-PE Dental Gel recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Vancomycin HCl in 0 recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

ALUM Concentrate / recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Profound Dental Gel recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Vancomycin HCl in 0 recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Profound Dental Gel recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Dexamethasone sodium phosphate 0 recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Edge Pharma product recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Lidocaine HCl Sterile Buffered Solution for Injection 1% recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Neostigmine methylsulfate recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Cefuroxime recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

CSF-HC Otic Insufflation Capsule recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Mitomycin-C recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Phenylephrine HCl/Tropicamide recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Phenol recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Mitomycin-C recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Edge Pharma product recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Phenylephrine HCl 0 recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Cantharidin Gel-Forming Suspension recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Methacholine Challenge 5-Syringe Test Kit recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Vancomycin HCl recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Lidocaine HCL / Bupivacaine HCL recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

PHENYLephrine recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Trypan Blue 0 recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

LT Topical Cream recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Lidocaine HCl/Phenylephrine HCl Nasal Solution recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Vancomycin HCl in 0 recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Ceftazidime recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

CSF Otic Insufflation Capsule recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Methotrexate recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Tetracaine HCl Nasal Solution recalled over manufacturing violations

December 6, 2021 · Drug & medication recalls Moderate risk CGMP Deviations

Phenylephrine HCl recalled over sterility concerns

December 6, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Betadine 5% recalled over sterility concerns

April 12, 2021 · Drug & medication recalls Moderate risk Defective container; syringe content migrating past the seal of the plunger may…

Methacholine Challenge 5-Syringe Test Kits recalled over temperature-control failures

February 17, 2021 · Drug & medication recalls Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) stora…

Edge Pharma, LLC recalls Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.…

December 22, 2020 · Drug & medication recalls Labeling: Incorrect or Missing Lot and/or Exp Date

Edge Pharma, LLC recalls Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01

July 2, 2020 · Drug & medication recalls Moderate risk Labeling: Label Error on Declared Strength

Methotrexate recalled over sterility concerns

March 19, 2020 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility; the media used to conduct post-compounding ster…

Edge Pharma product recalled over sterility concerns

March 19, 2020 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility; the media used to conduct post-compounding ster…