S-SODIUM SELINITE 0 recalled over sterility concerns

Recall date

August 12, 2019

Source

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

Official notice title

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx

Recall number

D-0250-2020

FDA classification

Class II

Brand / firm

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility

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

What was recalled

S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx