The Recall Desk
ModerateFDA (Drugs)·D-0848-2016·Announced 2016-05-18

Sesderma Recalls Repaskin 50 Sunscreen for cGMP Deviations

Sesderma is recalling 66 bottles of Repaskin 50 sunscreen due to cGMP deviations. The product was distributed to Florida, Puerto Rico, Colorado, and Georgia.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves cGMP deviations without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Sesderma, SL is recalling 66 bottles of Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube. The recall is due to cGMP deviations, meaning the product does not comply with current Good Manufacturing Practice requirements.

The affected product is identified by Lot code 51594901 and an expiration date of 06/18. It was distributed to the states of Florida, Puerto Rico, Colorado, and Georgia.

Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product
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
Manufacturer
Sesderma, SL
Category
Drug — Sunscreen
Hazard
Affected units
66

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot code 51594901
  • exp 06/18

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 10 recalled by Sesderma, SL under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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