TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL recalled over manufacturing violations

Recall date

April 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

NingBo Huize Commodity Co.,Ltd. recalls TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distribut…

Recall number

D-1549-2019

FDA classification

Class III

Brand / firm

NingBo Huize Commodity Co.,Ltd.

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.