Drug & medication recalls Moderate risk

Coppertone SUNSCREEN LOTION recalled over undeclared api

Recall date
May 10, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Bayer Health Care LLC recalls Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC,…
Recall number
D-0977-2016
FDA classification
Class II
Brand / firm
Bayer Health Care LLC
Sold / distributed
Nationwide

Why it was recalled

Labeling; Product Contains Undeclared API (Oxybenzone)

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

What was recalled

Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762

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