Drug & medication recalls Moderate risk

Dermatone Sunscreen Lotion Fragrance Free recalled over sterility concerns

Recall date
March 19, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Filltech USA, LLC recalls Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5…
Recall number
D-1241-2020
FDA classification
Class II
Brand / firm
Filltech USA, LLC
Sold / distributed
USA Nationwide

Why it was recalled

Microbial contamination of non-sterile products: positive test for yeast and bacteria.

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

What was recalled

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698

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