Drug product
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221
D-0846-2016
Product summary
- Firm
- Sesderma, SL
- Event
- Event 73574
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 354 bottles
- Official record key
drug-enforcement:D-0846-2016
Official wording
Reason: cGMP Deviations; product does not comply with cGMP requirements
Code information: Lot code 40414701, exp 09/19; Lot code 33524701, exp 10/18; Lot code 40144101, exp 10/18
Distribution pattern: Distributed to following states: FL, PR, CO, GA.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations