FDA-Drug2019-08-07Class III

Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China

NingBo Huize Commodity Co.,Ltd.
Hazard

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Sold states
Foreign manufacturer located in China and distributed to seven consignees located in China.
Affected count
5112
Manufactured in
14 Lizhou Road, N/A, Yuyao, N/A, China
Products
Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1531-2019

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