Premier Research Labs Recalls BiliVen Supplements Due to Undeclared Wheat
Premier Research Labs is recalling BiliVen capsules because they contain undeclared wheat, a major allergen.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves allergen mislabeling on a common allergen (wheat), which corresponds to a severity score of 3 (High) according to the rubric.
Plain-English summary
Premier Research Labs LP is voluntarily recalling approximately 49,830 bottles of BiliVen, a dietary supplement sold in 60-capsule dark plastic containers. The recall was initiated because the product contains undeclared wheat, which is a major food allergen. The affected product is identified by Item Number 2411 and UPC 0773502411.
The recalled BiliVen products were distributed in all 50 U.S. states and internationally to Canada, Hong Kong, Ireland, New Zealand, Singapore, the United Arab Emirates, the United Kingdom, Australia, Bermuda, Fiji, and Israel. Specific lot numbers involved in this recall are 111202-2411, 130411-2411, 130612-2411, and 130708-2411. The recall was initiated on October 22, 2014, and was classified as Class II by the FDA.
Consumers with this product should stop using it and contact Premier Research Labs for a refund or further information. Individuals with a wheat allergy or celiac disease should consult a healthcare professional if they have consumed the product.
The recalled product
- Product
- Premier Research Labs BiliVen, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each);Item Number 2411
- Manufacturer
- Premier Research Labs LP
- Category
- Food — Dietary Supplement
- Affected units
- 49,830
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Number: 111202-2411
- 130411-2411
- 130612-2411
- 130708-2411
- UPC 0773502411
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Premier Research Labs LP under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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