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Edge Pharma, LLC

Edge Pharma, LLC Recalls

All product recalls associated with Edge Pharma, LLC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 41–60 of 99 recalls

Phenol Injection Solution (Edge Pharma) – Sterility Concerns (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Dexamethasone Otic Solution (Edge Pharma) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Methacholine Challenge Kit (Edge Pharma) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDA

1 234 5

Page 3 of 5Next

Dec 6, 2021

Nationwide

• Edge Pharma, LLC

Trypan Blue Ophthalmic Solution (Edge Pharma) – manufacturing deviation (2021)

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Cefuroxime Ophthalmic Solution (Edge Pharma) – sterility issue (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Lidocaine/Epinephrine Injection (Edge Pharma) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Mitomycin-C Ophthalmic Solution (Edge Pharma) – sterility issue (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Lidocaine HCl Buffered Injection (Edge Pharma) – sterility issue (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Cantharidin Gel Suspension (Edge Pharma) – Manufacturing Deviation (2021)

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

BLT Topical Cream (Edge Pharma) – Manufacturing Deviation (2021)

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Phenol Topical Solution (Edge Pharma) – Manufacturing Deviation (2021)

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

MVASI Injection (Edge Pharma) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Edetate Disodium Ophthalmic Solution (Edge Pharma) – Sterility Concern (2021)

Lack of Assurance of Sterility.

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Edetate Disodium Ophthalmic Solution (Edge Pharma) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Profound-PE Dental Gel (Edge Pharma) – Manufacturing Deviation (2021)

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

LET Topical Gel (Edge Pharma) – Manufacturing Deviation (2021)

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Vancomycin Injection (Edge Pharma) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

ALUM Concentrate (Edge Pharma) – sterility concerns (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Promethazine HCl Ointment (Edge Pharma) – Manufacturing Deviation (2021)

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Vitamin K Oral Solution (Edge Pharma) – Manufacturing Deviation (2021)

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC