FDA recall D-0842-2016

Sesderma, SL · Class II · drug

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

Reason for recall

cGMP Deviations; product does not comply with cGMP requirements

Distribution

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

Key facts

Status
Ongoing
Initiation date
2015-10-15
Report date
2016-05-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rafelbunol, N/A, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0842-2016