Cicatricure — Class III drug recall D-0070-2019
Terminated recall by Product Quest Manufacturing LLC, reported 2018-10-24, distributed nationwide. Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
| Recall number | D-0070-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Product Quest Manufacturing LLC, Daytona Beach, FL, United States |
| Recall initiated | 2018-08-03 |
| Classified | 2018-10-16 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2021-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 7,944 tubes |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 00650067000187 |
| Lot numbers | 163241K |
| Expiration dates | 2018-10-20 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0070-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.