Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016

Recall Number: D-0843-2016

Firm: Sesderma, SL

Classification: Class II

Status: Ongoing

Report Date: 20160518

Initiation Date: 20151015

Termination Date:

cGMP Deviations; product does not comply with cGMP requirements

Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016