PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: May 18, 2016 Initiated: October 15, 2015 #D-0843-2016

Product Description

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

Reason for Recall

cGMP Deviations; product does not comply with cGMP requirements

Details

Recalling Firm
Sesderma, SL
Units Affected
459 bottles
Distribution
Distributed to following states: FL, PR, CO, GA.
Location
Rafelbunol, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Sesderma, SL. Units affected: 459 bottles.
Why was this product recalled?
cGMP Deviations; product does not comply with cGMP requirements
Which agency issued this recall?
This recall was issued by the FDA Drug on May 18, 2016. Severity: Moderate. Recall number: D-0843-2016.