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Profound Dental Gel (Edge Pharma) – manufacturing deviation (2021)

CGMP Deviations

FDADec 6, 2021Nationwide• Edge Pharma, LLC

Medique Pain-Off (Medique Products) – Manufacturing Deviation (2021)

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Class IIModerate

FDADec 6, 2021Nationwide• Medique Products

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Profound Dental Gel (Edge Pharma) – manufacturing deviation (2021)

Medique Pain-Off (Medique Products) – Manufacturing Deviation (2021)

Extra Strength Headache (Medique Products) – Manufacturing Deviation (2021)

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

Lidocaine/Phenylephrine Nasal (Edge Pharma) – Manufacturing Deviation (2021)

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

CSF Otic Insufflation (Edge Pharma) – Manufacturing Deviation (2021)

CariFree CTx4 Gel 5000 (Dental Alliance) - Low Sodium Fluoride (2021)

Morphine Sulfate Oral Solution (Akorn) – Missing Label Information (2021)

CariFree Sample Boxes (Dental Alliance) – Insufficient Sodium Fluoride (2021)

B-Complex Injection (Cape Drugs) – Processing Control Issues (2021)

CTx26 Kit (Dental Alliance) – Insufficient Sodium Fluoride (2021)

Methylcobalamin Injection (Cape Drugs) – Processing Control Issues (2021)

CTx7 Kit (Dental Alliance) – Insufficient Sodium Fluoride (2021)

CTx36 Kit (Dental Alliance) - Low Sodium Fluoride (2021)

Veklury (Gilead) - Glass Particulate Contamination (2021)

CTx21 Kit (Dental Alliance) - Low Sodium Fluoride (2021)

Oxycodone Hydrochloride Solution (Akorn) - Missing Label (2021)

CTx12 5000 Kit (Dental Alliance) - Low Sodium Fluoride (2021)

BUBS Naturals Collagen Protein – Undeclared Milk (2021)