FDA recall D-1547-2019

Product

AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (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.

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-1547-2019