FDA-Drug2018-10-24Class III

Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.

Product Quest Manufacturing LLC
Hazard

Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.

Sold states
Nationwide in the USA
Affected count
7,944 tubes
Manufactured in
330 Carswell Ave, N/A, Daytona Beach, FL, United States
Products
Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0070-2019

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief