ACETYLCYSTEINE OPTH 5% Solution recalled over sterility concerns

Recall date

October 7, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pharmacy Plus, Inc. dba Vital Care Compounder recalls ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 3…

Recall number

D-0027-2023

FDA classification

Class II

Brand / firm

Pharmacy Plus, Inc. dba Vital Care Compounder

Sold / distributed

AL, LA, MS, and TN

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402