Home / Recalls / Sesderma, SL / D-0843-2016

D-0843-2016 Class II Ongoing

Recalled by Sesderma, SL — Rafelbunol, N/A

Recall Details

Product Type
Drugs
Report Date
May 18, 2016
Initiation Date
October 15, 2015
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
459 bottles

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

Distribution Pattern

Distributed to following states: FL, PR, CO, GA.

Code Information

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

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