Recall record at a glance
| Official record | F-0592-2015 |
|---|---|
| Category | Food Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Premier Research Labs LP |
| Report date | Dec 10, 2014 |
| Recall initiation date | Oct 22, 2014 |
| Quantity | 49,830 bottles |
| Location | Austin, TX, United States |
Official product description
Premier Research Labs BiliVen, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each);Item Number 2411
Why the product was recalled
Undeclared wheat
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.