Class II
Ongoing
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
This recall is currently active, issued May 18, 2016. It was issued by Sesderma, Sl.
- Company
- Sesderma, Sl
- Recall Initiated
- October 15, 2015
- Posted
- May 18, 2016
- Recall Number
- D-0844-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 15 bottles
- Firm Location
- Rafelbunol, Spain
- Official Source
- View on FDA website ↗
Reason for Recall
cGMP Deviations; product does not comply with cGMP requirements
Distribution
Distributed to following states: FL, PR, CO, GA.
Lot / Code Info
Lot code 41464901, exp 05/17
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