FDA recall D-0328-2015

Tropichem Research Labs, Inc. · Class II · drug

Product

Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN

Reason for recall

Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli

Distribution

NY and IN.

Key facts

Status: Terminated
Initiation date: 2014-12-17
Report date: 2015-01-07
Termination date: 2017-05-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Jupiter, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0328-2015