PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: May 18, 2016 Initiated: October 15, 2015 #D-0848-2016

Product Description

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

Reason for Recall

cGMP Deviations; product does not comply with cGMP requirements

Details

Recalling Firm
Sesderma, SL
Units Affected
66 bottles
Distribution
Distributed to following states: FL, PR, CO, GA.
Location
Rafelbunol, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Sesderma, SL. Units affected: 66 bottles.
Why was this product recalled?
cGMP Deviations; product does not comply with cGMP requirements
Which agency issued this recall?
This recall was issued by the FDA Drug on May 18, 2016. Severity: Moderate. Recall number: D-0848-2016.