Recalls / Class III
Class IIID-0070-2019
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.
- Affected lot / code info
- Lot: 163241K, Exp. October 2018
Why it was recalled
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Recalling firm
- Firm
- Product Quest Manufacturing LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 330 Carswell Ave, N/A, Daytona Beach, Florida 32117-4416
Distribution
- Quantity
- 7,944 tubes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-08-03
- FDA classified
- 2018-10-16
- Posted by FDA
- 2018-10-24
- Terminated
- 2021-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0070-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.