FDA recall D-1564-2019

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

Product

Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.

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-1564-2019