FDAClass IIMay 18, 2016

Salises Facial Moisturizing Acne Treatment Gel recall: CGMP Deviations

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.…

Why was Salises Facial Moisturizing Acne Treatment Gel recalled?

cGMP Deviations; product does not comply with cGMP requirements

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot code 51004101, exp 2/2020, lot 43394101, exp 11/2019, lot 33444101, exp 11/2018

Product
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.…
Recalling firm
Sesderma, SL
Quantity
459 bottles
Distribution
Distributed to following states: FL, PR, CO, GA.
Recall date
May 18, 2016
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls