D-0070-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 24, 2018
- Initiation Date
- August 3, 2018
- Termination Date
- March 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