Product: Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ  85253; Manufactured by: Cornerstone Research and Development, Ogden, UT  84404, NDC 68040-602-16.
Reason for recall: Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Recall initiated: 20180126
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated