Drug & medication recalls Moderate risk

Dry 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 Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51…
Recall number
D-1127-2019
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

Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactured by: MSM Nutraceuticals, LLC, UPC 8 54582 00119 7.

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