PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: August 7, 2019 Initiated: April 1, 2019 #D-1541-2019

Product Description

DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (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.

Details

Units Affected
3852
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?
DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.. Recalled by NingBo Huize Commodity Co.,Ltd.. Units affected: 3852.
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-1541-2019.