Drug product
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691
D-0845-2016
Product summary
- Firm
- Sesderma, SL
- Event
- Event 73574
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 bottles
- Official record key
drug-enforcement:D-0845-2016
Official wording
Reason: cGMP Deviations; product does not comply with cGMP requirements
Code information: Lot code 41274901, exp 2/19.
Distribution pattern: Distributed to following states: FL, PR, CO, GA.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations