FDA recall D-1561-2019

NingBo Huize Commodity Co.,Ltd. · Class III · drug

Product

DIPPIN' DOTS SCENTED BIRTHDAY CAKE 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

Foreign manufacturer located in China and distributed to seven consignees located in China.

Key facts

Status: Terminated
Initiation date: 2019-04-01
Report date: 2019-08-07
Termination date: 2023-06-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Yuyao, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1561-2019