US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 20, 2019 (7 years ago)

Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of sterility assurance.

What was recalled

Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800

Recalling firm
Assurance Infusion
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0663-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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Reason Chemical contamination: Presence of benzene

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Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

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Class II · Moderate risk Ongoing

Autologus Tears Serum Soln Full Strength

Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Pharmacy Plus, Inc. dba Vital Care Compounder D-0028-2023
Class II · Moderate risk Terminated

Skincell Mole & Skin Corrector Serum

Reason Marketed Without An Approved NDA/ANDA; Unapproved new drug

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Class II · Moderate risk Terminated

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Reason Marketed Without An Approved NDA/ANDA; Unapproved new drug

Justified Laboratories D-0008-2023