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Primus announces recall of Limbrel®

by
Optum Workers' Comp
| Jan 31, 2018

In an effort to cooperate with the U.S. Food and Drug Administration’s (FDA) request to recall Limbrel, Primus Pharmaceuticals announced it is now voluntarily recalling all unexpired lots of this prescription medical food. Limbrel is used to manage the metabolic processes associated with osteoarthritis.

We have been providing updates about this situation since November when the FDA issued its first warning to consumers and health professionals regarding potential adverse events, including two life-threatening health problems associated with Limbrel.

All unexpired lots of the following products are included in this recall:

Product Name, Strength, Dosage Form

National Drug Code

Limbrel (flavocoxid) 250 mg capsules

68040-601-16

Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules

68040-605-16

Limbrel (flavocoxid) 500 mg capsules

68040-602-16

Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules

68040-606-16

Primus will be notifying its distributors by email and arranging for the return of all recalled products. Any retail pharmacies with Limbrel products in stock should return them to their wholesale distributor.

Claimants who have Limbrel should stop taking the product as recommended by the FDA and contact their physician or healthcare provider to discuss alternative treatments and inform them if they have experienced any adverse event related to taking Limbrel. If claimants wish to return unopened bottles or have questions regarding this recall, they can go to www.limbrel.com or contact Primus directly by calling 1-480-483-1410 on Monday through Friday, 9 AM to 5 PM Mountain Time.

For more information on this recall from Primus, please click here

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.


Source:

  1. U.S. Food and Drug Administration Safety Recalls, Market Withdrawals and Safety Alerts. Company Announcement. Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA's Cooperation to Restore Access for Patients with Medical Necessity. January 26, 2018. Available at: https://www.fda.gov/Safety/Recalls/ucm594357.htm


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