The Recall Desk
ModerateFDA (Drugs)·D-0844-2016·Announced 2016-05-18

Sesderma Recalls Repaskin 50 Sunscreen Due to cGMP Deviations

Sesderma is recalling 15 tubes of Repaskin 50 sunscreen because the product does not comply with current Good Manufacturing Practice (cGMP) requirements.

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, which typically indicates a situation where use of the product might cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The source text cites cGMP deviations without reporting specific injuries or illnesses, aligning with a Moderate severity rating for a voluntary compliance recall.

Plain-English summary

Sesderma, SL is recalling 15 tubes of Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL). The product is identified by Lot code 41464901 and an expiration date of 05/17.

The recall was initiated because the product does not comply with current Good Manufacturing Practice (cGMP) requirements. The agency has classified this recall as Class II.

The affected product was distributed to Florida, Puerto Rico, Colorado, and Georgia. Consumers should check their inventory for the specific lot code and expiration date listed above. If the product matches the description, consumers should stop using it and contact the manufacturer for instructions.

The recalled product

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
Manufacturer
Sesderma, SL
Category
Drug — Sunscreen
Hazard
Affected units
15

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 41464901
  • exp 05/17

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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