FDAClass IIMay 18, 2016

Repaskin 50 recall: CGMP Deviations

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…

Why was Repaskin 50 recalled?

cGMP Deviations; product does not comply with cGMP requirements

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot code 41464901, exp 05/17

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…
Recalling firm
Sesderma, SL
Quantity
15 bottles
Distribution
Distributed to following states: FL, PR, CO, GA.
Recall date
May 18, 2016
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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