Why it was recalled
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Product description
Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60
Lot numbers, UPCs & expiration codes
SKU#: a) 8C52541, b) 8B41841, c) 1155840, 1155841, 1155842, 1155851, 0710341, 0710342
Where it was sold
Product was distributed nationwide.
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-0215-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 14, 2017
- FDA report date
- Jan 24, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SHISEIDO AMERICA INC.
Original FDA data
Every field from FDA enforcement report D-0215-2018, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78791
- Address
- 366 Princeton Hightstown Rd
- Code information
- SKU#: a) 8C52541, b) 8B41841, c) 1155840, 1155841, 1155842, 1155851, 0710341, 0710342
- Postal code
- 08520-1411
- Report date
- Jan 24, 2018
- Product type
- Drugs
- Recall number
- D-0215-2018
- Classification
- Class II
- Recalling firm
- SHISEIDO AMERICA INC.
- Termination date
- Jun 24, 2021
- Reason for recall
- GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Dec 14, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 12, 2018