Drug product
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
D-0849-2016
Product summary
- Firm
- Sesderma, SL
- Event
- Event 73574
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27 bottles
- Official record key
drug-enforcement:D-0849-2016
Official wording
Reason: cGMP Deviations; product does not comply with cGMP requirements
Code information: Lot code 51064901, exp 07/17; Lot code 51064902, exp 04/18
Distribution pattern: Distributed to following states: FL, PR, CO, GA.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations