D-0070-2019 Class III Terminated
FDA drug recall D-0070-2019 was initiated by Product Quest Manufacturing LLC on Aug 3, 2018 and is designated Class III. Reason for recall: Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients. The recall status is terminated (terminated Mar 30, 2021). Affected quantity: 7,944 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 24, 2018
- Initiation Date
- Aug 3, 2018
- Termination Date
- Mar 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,944 tubes
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 163241K, Exp. October 2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0070-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026