FDA Drug recall D-0844-2016
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…
- FDA Drug
- Class II
- ongoing
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class II recall of 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… by Sesderma Sl, citing cGMP Deviations; product does not comply with cGMP requirements.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0844-2016 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2015-10-15 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sesderma Sl |
| Distribution | CO, FL, GA, PR |
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
cGMP Deviations; product does not comply with cGMP requirements
Identifiers
| upc | 8429979415707 |
|---|---|
| code_info | Lot code 41464901, exp 05/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0844-2016%22
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