Drug 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
D-0843-2016
Product summary
- Firm
- Sesderma, SL
- Event
- Event 73574
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 459 bottles
- Official record key
drug-enforcement:D-0843-2016
Official wording
Reason: cGMP Deviations; product does not comply with cGMP requirements
Code information: Lot code 51004101, exp 2/2020, lot 43394101, exp 11/2019, lot 33444101, exp 11/2018
Distribution pattern: Distributed to following states: FL, PR, CO, GA.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations