D-1558-2019 Class III Terminated
FDA drug recall D-1558-2019 was initiated by NingBo Huize Commodity Co.,Ltd. on April 1, 2019 and is designated Class III. Reason for recall: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. The recall status is terminated (terminated June 6, 2023). Affected quantity: 13,068.
Recall Details
- Product Type
- Drugs
- Report Date
- August 7, 2019
- Initiation Date
- April 1, 2019
- Termination Date
- June 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,068
Product Description
ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Reason for Recall
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Distribution Pattern
Foreign manufacturer located in China and distributed to seven consignees located in China.
Code Information
Lot #: 20181204, Exp 12/3/2020; 20181205, Exp 12/4/2020