Primus Pharmaceuticals, Inc. has agreed to conduct a Limbrel recall, as U.S. health regulators continue to investigate adverse events linking the product to potentially serious side effects, including drug-induced liver injury and hypersensitivity pneumonitis.
The U.S. Food & Drug Administration (FDA) formally requested a Limbrel recall in December. Primus is notifying distributors by emailed letter and is arranging for the return of all recalled Limbrel products.
The voluntary recall includes:
The FDA has advised patients not to use any recalled products in their possession.
Patients seeking to return unopened bottles of Limbrel should go to Limbrel.com or contact Primus by calling (480-483-1410), Monday through Friday, 9 AM to 5 PM MT. Patients should contact their physician or healthcare provider if they have experienced any adverse event that may be related to Limbrel.
Symptoms of drug-induced liver include:
Those associated with hypersensitivity pneumonitis include:
Limbrel has been on the market since 2004. A prescription-only medical food, Limbrel products are used to “manage the metabolic processes associated with osteoarthritis.”
The FDA warned consumers not to use Limbrel in November, after the products had been linked to 194 adverse event reports.
“In 30 of those cases, there was sufficient information for FDA medical experts to determine that Limbrel was likely associated with these adverse events,” the agency’s press release stated.
By December 4th, the number of adverse event reports received by the agency in connection with Limbrel had grown to 200.
The FDA issued a letter to Primus on December 18th formally requesting a Limbrel recall. The company voluntarily suspended promotion and sale of Limbrel on December 21st.