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Recall Observatory FDA recall evidence

Food product

Premier Research Labs BiliVen, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each);Item Number 2411

F-0592-2015

October 22, 2014

Class II

Product summary

Firm
Premier Research Labs LP
Event
Event 69561
Status
Terminated
Classification
Class II
Quantity
49,830 bottles
Official record key
food-enforcement:F-0592-2015

Official wording

Reason: Undeclared wheat

Code information: Lot Number: 111202-2411, 130411-2411, 130612-2411, 130708-2411; UPC 0773502411

Distribution pattern: 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.

Derived failure modes

  • Undeclared allergen

    reason.undeclared_allergen · v1.0.0

    Undeclared wheat