Red Eye recalled over sterility concerns

Recall date

March 12, 2019

Source

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

Official notice title

MSM Nutraceuticals, LLC recalls Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.1…

Recall number

D-1128-2019

FDA classification

Class II

Brand / firm

MSM Nutraceuticals, LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

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

What was recalled

Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0