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Class II: temporary or reversible health riskTerminated

Premier Research Labs Quantum Gallbladder Support Recall

Quantum Gallbladder Support, 60 capsules in dark plastic container, each capsule is 460…

Premier Research Labs LP · Austin, TX

Risk level
Class II
Reported by FDA
Dec 10, 2014
Recall ID
F-0591-2015
Check your lot numberHow we source this data

Summary

Premier Research Labs recalled Quantum Gallbladder Support starting Oct 22, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-0591-2015 on Dec 10, 2014. Reason: Undeclared wheat. Status: Terminated.

Why it was recalled

Undeclared wheat

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

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.

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0591-2015
Classification
Class II
Status
Terminated
Recall initiated
Oct 22, 2014
FDA report date
Dec 10, 2014
Quantity
7101 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Premier Research Labs LP

Original FDA data

Every field from FDA enforcement report F-0591-2015, exactly as published.

Show all FDA fields
City
Austin
State
TX
Status
Terminated
Country
United States
Event ID
69561
Address
3500 Wadley Pl
Address (line 2)
Ste B
Code information
Lot Number: 111202-12411, 130411-12411, 130612-12411, 130708-12411
Postal code
78728-1279
Report date
Dec 10, 2014
Product type
Food
Recall number
F-0591-2015
Classification
Class II
Recalling firm
Premier Research Labs LP
Product quantity
7101 bottles
Termination date
Mar 2, 2017
Reason for recall
Undeclared wheat
Voluntary / mandated
Voluntary: Firm initiated
Product description
Quantum Gallbladder Support, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each; Item Number 12411; UPC 0773512411
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.
Recall initiation date
Oct 22, 2014
Initial firm notification
E-Mail
Center classification date
Dec 1, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0591-2015, published Dec 10, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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