Medical Food Used for Managing Osteoarthritis Recalled at FDA's Request
Primus announced a voluntary recall of all unexpired lots of Limbrel (flavocoxid [contains two types of flavonoids from Scutellaria baicalensis and Acacia catechu]) due to rare but serious and reversible adverse effects associated with the product.
Limbrel, a medical food product, is indicated for dietary management of the metabolic processes of osteoarthritis.
Between January 1, 2007 and November 9, 2017, the Food and Drug Administration (FDA) had received 30 adverse event reports related to elevated liver function tests or acute hypersensitivity pneumonitis associated with the use of Limbrel. An independent review, conducted by Primus, found no basis on which to conclude that Limbrel potentially causes life-threatening adverse effects.
Nevertheless, at the FDA's request, Primus is recalling all unexpired lots of the following products:
- Limbrel 250mg capsules, Product Identity Number 68040-601-16
- Limbrel250 (250mg flavocoxid with 50mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-605-16
- Limbrel 500mg capsules, Product Identity Number 68040-602-16
- Limbrel500 (500mg flavocoxid with 50mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-606-16
The Company is contacting distributors and arranging for return of all recalled products. Patients in possession of the affected products are recommended to discontinue use.
In a press release, Primus notes that several physicians have provided written testimony to the FDA confirming the benefits and safety of Limbrel, especially for elderly patients with comorbidities who cannot take nonsteroidal antiinflammatory drugs (NSAIDs) and do not wish to take opioids. The Company will be working with the FDA to bring the product back to market as soon as possible
For more information call (480) 483-1410 or visit Limbrel.com.