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
D-0842-2016
Product summary
- Firm
- Sesderma, SL
- Event
- Event 73574
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 542 bottles
- Official record key
drug-enforcement:D-0842-2016
Official wording
Reason: cGMP Deviations; product does not comply with cGMP requirements
Code information: Lot code 40444601, exp 01/2019; Lot code 41414601, exp 05/2019; Lot code 40024602, exp 12/2018
Distribution pattern: Distributed to following states: FL, PR, CO, GA.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations