FDA-Drug2016-05-18Class II

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

Sesderma, SL
Hazard

cGMP Deviations; product does not comply with cGMP requirements

Sold states
Distributed to following states: FL, PR, CO, GA.
Affected count
459 bottles
Manufactured in
Calle Massamagrell 3-5, Poligono Industrial Rafelbunol, Rafelbunol, N/A, Spain
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0843-2016

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