Why it was recalled
cGMP Deviations; product does not comply with cGMP requirements
Product description
Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
Lot numbers, UPCs & expiration codes
Lot code 41464901, exp 05/17
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-0844-2016
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 15, 2015
- FDA report date
- May 18, 2016
- Quantity
- 15 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sesderma, SL
Original FDA data
Every field from FDA enforcement report D-0844-2016, 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 41464901, exp 05/17
- Report date
- May 18, 2016
- Product type
- Drugs
- Recall number
- D-0844-2016
- Classification
- Class II
- Recalling firm
- Sesderma, SL
- Product quantity
- 15 bottles
- Reason for recall
- cGMP Deviations; product does not comply with cGMP requirements
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
- 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