Drug & medication recalls Moderate risk

MSM Nutraceuticals product 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 Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hill…
Recall number
D-1129-2019
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

Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036

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