FDA recall F-0591-2015

Premier Research Labs LP · Class II · food

Product

Quantum Gallbladder Support, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each; Item Number 12411; UPC 0773512411

Reason for recall

Undeclared wheat

Distribution

Gallbladder Support products were distributed in all states in the US as well as internationally to Canada, Ecuador, and Singapore. BiliVen products were distributed in all states in the US as well as internationally to Canada, Hong Kong, Ireland, New Zealand, Singapore, United Arab Emirates, United Kingdom, Australia, Bermuda, Fiji, and Israel.

Key facts

Status: Terminated
Initiation date: 2014-10-22
Report date: 2014-12-10
Termination date: 2017-03-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0591-2015