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Showing 1681–1700 of 9558 results

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Cefuroxime Ophthalmic Solution (Edge Pharma) – sterility issue (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

Cantharidin Gel Suspension (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

Phenylephrine HCl Solution (Edge Pharma) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

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

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Dibutyl Squaric Acid Topical Solution (Edge Pharma) – CGMP deviation (2021)

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Moxifloxacin Ophthalmic Solution (Edge Pharma) – sterility concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Phenylephrine HCl/Tropicamide/Ciprofloxacin/Ketorolac (Edge Pharma) – sterility issue (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Vancomycin HCl Sodium Chloride Injection (Edge Pharma) – sterility issue (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

NaturesPlus Glucosamine (Ambix Laboratories) – Microbial Contamination (2021)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.

Class IIModerate

FDADec 6, 2021NY• Organics Corporation of America DBA Ambix Laboratories

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac (Edge Pharma) – sterility issue (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Vancomycin Sodium Chloride (Edge Pharma) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Vancomycin HCl Ophthalmic (Edge Pharma) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Ceftazidime Ophthalmic (Edge Pharma) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Gemcitabine Intravesical Solution (Edge Pharma) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Dibutyl Squaric Acid Solution (Edge Pharma) – manufacturing issues (2021)

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC

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