FDA Drug recall D-0843-2016
Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderm…
- FDA Drug
- Class II
- ongoing
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class II recall of Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderm… by Sesderma Sl, citing cGMP Deviations; product does not comply with cGMP requirements.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0843-2016 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2015-10-15 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sesderma Sl |
| Distribution | CO, FL, GA, PR |
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., Valencia, Spain --- NDC 63181-0016
Reason
cGMP Deviations; product does not comply with cGMP requirements
Identifiers
| code_info | Lot code 51004101, exp 2/2020, lot 43394101, exp 11/2019, lot 33444101, exp 11/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0843-2016%22
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