FDA recall D-0849-2016

Product

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1

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-0849-2016