Recalls / Class II

Class IID-0848-2016

Product

Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1

Affected lot / code info

Lot code 51594901, exp 06/18,

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

66 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-0848-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.