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Recall Observatory FDA recall evidence

Drug 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

D-0847-2016

October 15, 2015

Class II

Product summary

Firm
Sesderma, SL
Event
Event 73574
Status
Ongoing
Classification
Class II
Quantity
195 bottles
Official record key
drug-enforcement:D-0847-2016

Official wording

Reason: cGMP Deviations; product does not comply with cGMP requirements

Code information: Lot code 33454701, exp 11/18, lot 40424701, exp 1/2019

Distribution pattern: Distributed to following states: FL, PR, CO, GA.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations