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Edenbridge Pharmaceuticals, LLC

Edenbridge Pharmaceuticals, LLC Recalls

All product recalls associated with Edenbridge Pharmaceuticals, LLC.

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Recall Summary

Total Recalls

99

Past Year

0

Class I (Serious)

1

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 1–20 of 99 recalls

Opium Tincture (Edenbridge) – Subpotent Medication (2023)

Subpotent Drug

FDAOct 20, 2023Nationwide• Edenbridge Pharmaceuticals, LLC

Flunisolide Nasal Solution (Ingenus) – substance impurity (2022)

Out of specification for related substances (impurities).

Class IIModerate

FDASep 30, 2022Nationwide• Ingenus Pharmaceuticals Llc

Estriol Vaginal Cream (Wedgewood) - Unsanitary Conditions (2022)

Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Class IIModerate

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FDAJun 10, 2022Nationwide• Wedgewood Village Pharmacy, LLC

Bethanechol Chloride Suspension (Wedgewood) - Unsanitary Conditions (2022)

Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Class IIModerate

FDAJun 10, 2022Nationwide• Wedgewood Village Pharmacy, LLC

Boric Acid Capsules (Wedgewood) - Unsanitary Conditions (2022)

Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Class IIModerate

FDAJun 10, 2022Nationwide• Wedgewood Village Pharmacy, LLC

Estriol Vaginal Cream (Wedgewood) - Unsanitary Conditions (2022)

Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Class IIModerate

FDAJun 10, 2022Nationwide• Wedgewood Village Pharmacy, LLC

Doxycycline Suspension (Wedgewood) - Unsanitary Conditions (2022)

Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Class IIModerate

FDAJun 10, 2022Nationwide• Wedgewood Village Pharmacy, LLC

Boric Acid Vaginal Suppositories (Wedgewood) - Unsanitary Conditions (2022)

Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Class IIModerate

FDAJun 10, 2022Nationwide• Wedgewood Village Pharmacy, LLC

Clobetasol Propionate Foam (Ingenus) – CGMP Issues (2022)

CGMP Deviations

Class IIModerate

FDAJan 10, 2022Nationwide• Ingenus Pharmaceuticals Llc

MVASI Injection (Edge Pharma) – Sterility Concern (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

Cefuroxime Ophthalmic Solution (Edge Pharma) – sterility issue (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

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

CGMP Deviations

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

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

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

Lack of Assurance of Sterility

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

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

CGMP Deviations

Class IIModerate

FDADec 6, 2021Nationwide• Edge Pharma, LLC