The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0847-2016·Announced 2016-05-18

Sesderma Dryses Deodorant Recalled for cGMP Deviations

Sesderma is recalling 195 bottles of Dryses Aluminum Chlorohydrate Deodorant for Women due to cGMP deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text cites cGMP deviations without reporting specific illnesses or injuries, aligning with a moderate severity assessment.

Plain-English summary

Sesderma, SL is recalling 195 bottles of Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle. The product is an over-the-counter deodorant manufactured in Valencia, Spain. The recall is being conducted because the product does not comply with current Good Manufacturing Practice (cGMP) requirements.

The affected product is identified by NDC 16047-0029-1. Specific lot codes include 33454701 with an expiration date of 11/18, and lot 40424701 with an expiration date of 1/2019. The product was distributed to the states of Florida, Puerto Rico, Colorado, and Georgia.

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1
Manufacturer
Sesderma, SL
Category
Drug — Deodorant
Hazard
Affected units
195

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 (4)

  • Lot code 33454701
  • exp 11/18
  • lot 40424701
  • exp 1/2019

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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