Drug product
Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166
D-0850-2016
Product summary
- Firm
- Sesderma, SL
- Event
- Event 73574
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 45 compacts
- Official record key
drug-enforcement:D-0850-2016
Official wording
Reason: cGMP Deviations; product does not comply with cGMP requirements
Code information: Lot code H-04, exp 07/2019
Distribution pattern: Distributed to following states: FL, PR, CO, GA.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations