Why it was recalled
cGMP Deviations; product does not comply with cGMP requirements
Product description
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
Lot numbers, UPCs & expiration codes
Lot code 40444601, exp 01/2019; Lot code 41414601, exp 05/2019; Lot code 40024602, exp 12/2018
Where it was sold
Distributed to following states: FL, PR, CO, GA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0842-2016
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 15, 2015
- FDA report date
- May 18, 2016
- Quantity
- 542 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sesderma, SL
Original FDA data
Every field from FDA enforcement report D-0842-2016, exactly as published.
Show all FDA fields
- City
- Rafelbunol
- Status
- Ongoing
- Country
- Spain
- Event ID
- 73574
- Address
- Calle Massamagrell 3-5
- Address (line 2)
- Poligono Industrial Rafelbunol
- Code information
- Lot code 40444601, exp 01/2019; Lot code 41414601, exp 05/2019; Lot code 40024602, exp 12/2018
- Report date
- May 18, 2016
- Product type
- Drugs
- Recall number
- D-0842-2016
- Classification
- Class II
- Recalling firm
- Sesderma, SL
- Product quantity
- 542 bottles
- Reason for recall
- cGMP Deviations; product does not comply with cGMP requirements
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed to following states: FL, PR, CO, GA.
- Recall initiation date
- Oct 15, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 10, 2016