FDA Recall D-1176-2023

HUMANRACE · Beverly Hills, CA

Class II Ongoing 1000 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002

Lot / code: Lot #: 1752A, 1752B, 1782E, 1782G, 1782C, 1752C, 1782B; Exp. 06/2024.

Quantity: 2942 units

Reason for recall

Subpotent Drug: Product does not contain SPF that is declared on the label.

Recall record

Recall number: D-1176-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA, Spain, Italy, UK, and France.
Recall initiated: 2023-08-18
Classified by FDA Center: 2023-09-21
FDA published: 2023-09-27
Recalling firm: HUMANRACE
Firm location: Beverly Hills, CA

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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