Recalls / Class II

Class IID-0849-2016

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

Affected lot / code info

Lot code 51064901, exp 07/17; Lot code 51064902, exp 04/18

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

27 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-0849-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.