US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 26, 2016 (10 years ago)

Autologous Serum Tears

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

Why it was recalled

Lack of Assurance of Sterility

What was recalled

Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402

Recalling firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Origin
MS, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1541-2016

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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Serum Tears in Nsal 20% Opth Solution

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

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