FDA recall D-0851-2016

Sesderma, SL · Class II · drug

Product

Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159

Reason for recall

cGMP Deviations; product does not comply with cGMP requirements

Distribution

Distributed to following states: FL, PR, CO, GA.

Key facts

Status
Ongoing
Initiation date
2015-10-15
Report date
2016-05-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rafelbunol, N/A, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0851-2016