Recalls / Class II
Class IID-0845-2016
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
- Affected lot / code info
- Lot code 41274901, exp 2/19.
Why it was recalled
cGMP Deviations; product does not comply with cGMP requirements
Recalling firm
- Firm
- Sesderma, SL
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- Calle Massamagrell 3-5, Poligono Industrial Rafelbunol, Rafelbunol, N/A N/A, Spain
Distribution
- Quantity
- 20 bottles
- Distribution pattern
- Distributed to following states: FL, PR, CO, GA.
Timeline
- Recall initiated
- 2015-10-15
- FDA classified
- 2016-05-10
- Posted by FDA
- 2016-05-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0845-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.