PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: August 7, 2019 Initiated: April 1, 2019 #D-1531-2019

Product Description

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

Reason for Recall

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

Details

Units Affected
5112
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.
Location
Yuyao, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by NingBo Huize Commodity Co.,Ltd.. Units affected: 5112.
Why was this product recalled?
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 7, 2019. Severity: Low. Recall number: D-1531-2019.