Repaskin 50 — Class II drug recall D-0844-2016
Ongoing recall by Sesderma, SL, reported 2016-05-18, distributed in CO, FL, GA, PR. cGMP Deviations; product does not comply with cGMP requirements
| Recall number | D-0844-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sesderma, SL, Rafelbunol, N/A, Spain |
| Recall initiated | 2015-10-15 |
| Classified | 2016-05-10 |
| Reported by FDA | 2016-05-18 |
| Distributed | CO, FL, GA, PR |
| Quantity | 15 bottles |
| Reason classes | cgmp |
| NDC | 63181-0013-01 |
| Lot numbers | 05/17, 41464901 |
Product
Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
Reason for recall
cGMP Deviations; product does not comply with cGMP requirements
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0844-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.