FDA recall D-0069-2019

Product Quest Manufacturing LLC · Class III · drug

Product

Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2018-08-03
Report date
2018-10-24
Termination date
2021-03-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Daytona Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0069-2019