PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: October 24, 2018 Initiated: August 3, 2018 #D-0070-2019

Product Description

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.

Reason for Recall

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

Details

Units Affected
7,944 tubes
Distribution
Nationwide in the USA
Location
Daytona Beach, FL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Product Quest Manufacturing LLC. Units affected: 7,944 tubes.
Why was this product recalled?
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 24, 2018. Severity: Low. Recall number: D-0070-2019.