FDA Recall D-0843-2016
Sesderma, SL · Rafelbunol, N/A
Class II Ongoing 3864 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
cGMP Deviations; product does not comply with cGMP requirements
Recall record
- Recall number
D-0843-2016- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Recall initiated
- 2015-10-15
- Classified by FDA Center
- 2016-05-10
- FDA published
- 2016-05-18
- Recalling firm
- Sesderma, SL
- Firm location
- Rafelbunol, N/A, Spain
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.