Food Recall Check
Class II · Moderate risk Terminated Initiated Oct 22, 2014 (12 years ago)

Premier Research Labs BiliVen recall

Recalled by Premier Research Labs LP · Austin, TX, United States

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Undeclared wheat

Undeclared allergen: Wheat

For someone with a food allergy the label is the only protection. An undeclared allergen can trigger a severe reaction even in a trace amount, which is why most of these recalls are Class I. All undeclared allergens recalls.

What was recalled

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

Quantity: 49,830 bottles

Food: Dietary supplements

Lot codes, dates and UPCs

A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.

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

Where it was sold

Nationwide.

FDA's distribution note: 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.

Check the codes, then return or discard. Class II means eating it may cause temporary or reversible health problems. If your package matches the recalled codes, do not eat it - return it to the store or throw it away. The risk from an undeclared allergen is to people allergic to wheat; for anyone else the product is generally not a safety concern. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.

Recalling firm
Premier Research Labs LP
Initiated by
Voluntary: Firm initiated
Recall initiated
Oct 22, 2014
In FDA report of
Dec 10, 2014
Terminated
Mar 2, 2017
FDA recall number
F-0592-2015 · event 69561
Official record
FDA enforcement report search

Also recalled with it (1 more product)

FDA files each product of one recall action separately; these share the same FDA event.

Recent dietary supplements recalls

All dietary supplements recalls