Why it was recalled
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Product description
DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Lot numbers, UPCs & expiration codes
Lot #: 20181024, Exp 10/23/2020
Where it was sold
Foreign manufacturer located in China and distributed to seven consignees located in China.
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-1541-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 1, 2019
- FDA report date
- Aug 7, 2019
- Quantity
- 3852
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- NingBo Huize Commodity Co.,Ltd.
Original FDA data
Every field from FDA enforcement report D-1541-2019, exactly as published.
Show all FDA fields
- City
- Yuyao
- Status
- Terminated
- Country
- China
- Event ID
- 83018
- Address
- 14 Lizhou Road
- Code information
- Lot #: 20181024, Exp 10/23/2020
- Report date
- Aug 7, 2019
- Product type
- Drugs
- Recall number
- D-1541-2019
- Classification
- Class III
- Recalling firm
- NingBo Huize Commodity Co.,Ltd.
- Product quantity
- 3852
- Termination date
- Jun 6, 2023
- Reason for recall
- CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
- Distribution pattern
- Foreign manufacturer located in China and distributed to seven consignees located in China.
- Recall initiation date
- Apr 1, 2019
- Initial firm notification
- Telephone
- Center classification date
- Jul 27, 2019