The Recall Desk
ModerateFDA (Drugs)·D-0842-2016·Announced 2016-05-18

Sesderma Recalls Dryses Antiperspirant Solution for cGMP Deviations

Sesderma is recalling 542 bottles of Dryses Aluminum Chlorohydrate Antiperspirant Solution because the product does not comply with 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 due to cGMP deviations. Per the rubric, this falls under 'voluntary precautionary recalls' or minor compliance issues where no specific injuries or illnesses are reported, aligning with a Moderate severity score.

Plain-English summary

Sesderma, SL is recalling 542 bottles of Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottles. The product is over-the-counter and was manufactured in Valencia, Spain. 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 NDC 63181-0015-1 and UPC 8 470003 244268. The recall includes three specific lot codes: 40444601 (exp 01/2019), 41414601 (exp 05/2019), and 40024602 (exp 12/2018). The product was distributed to Florida, Puerto Rico, Colorado, and Georgia.

Consumers who have this product should stop using it and contact the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268
Manufacturer
Sesderma, SL
Category
Drug — Antiperspirant
Hazard
Affected units
542

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 (6)

  • Lot code 40444601
  • exp 01/2019
  • Lot code 41414601
  • exp 05/2019
  • Lot code 40024602
  • exp 12/2018

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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