Primus Pharmaceuticals, Inc. recalls Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsda

Recalled February 21, 2018 · FDA recall D-0344-2018 · Primus Pharmaceuticals

Hazard

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. · FDA Class I

Units

7,826 bottles

Sold at

Nationwide in the USA.

Description

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.

Product

Limbrel (flavocoxid 250 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 68040-601-16.

Manufacturer(s)

Primus Pharmaceuticals, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →