Drug & medication recalls Moderate risk

SHEER DesenZ Desensitizing Treatment recalled over manufacturing violations

Recall date
November 16, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
CAO Group, Inc. recalls SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive…
Recall number
D-0291-2019
FDA classification
Class II
Brand / firm
CAO Group, Inc.
Sold / distributed
Nationwide in the US

Why it was recalled

cGMP violations noted during the firm's most recent inspection.

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

What was recalled

SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304

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