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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69561

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 22, 2014
Product types
Food
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Premier Research Labs LP

Dossier provenance

Source snapshots represented here

  • openFDA Food Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

food · product 1 of 2

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

F-0591-2015
Recall number
F-0591-2015
Initiated
October 22, 2014
Classification
Class II
Status
Terminated
Recalling firm
Premier Research Labs LP
Quantity
7101 bottles

App-derived interpretation

Undeclared allergen reason.undeclared_allergen · v1.0.0
Undeclared wheat

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Undeclared wheat

Code information

Lot Number: 111202-12411, 130411-12411, 130612-12411, 130708-12411

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.

food · product 2 of 2

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
Recall number
F-0592-2015
Initiated
October 22, 2014
Classification
Class II
Status
Terminated
Recalling firm
Premier Research Labs LP
Quantity
49,830 bottles

App-derived interpretation

Undeclared allergen reason.undeclared_allergen · v1.0.0
Undeclared wheat

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.