FDA Drug Recalls

Recalls / Class II

Class IID-0847-2016

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

Affected lot / code info
Lot code 33454701, exp 11/18, lot 40424701, exp 1/2019

Why it was recalled

cGMP Deviations; product does not comply with cGMP requirements

Recalling firm

Firm
Sesderma, SL
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
Calle Massamagrell 3-5, Poligono Industrial Rafelbunol, Rafelbunol, N/A N/A, Spain

Distribution

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

Timeline

Recall initiated
2015-10-15
FDA classified
2016-05-10
Posted by FDA
2016-05-18
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0847-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.