Primus Pharmaceuticals, Inc. recalls Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured fo…

Recall date

January 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0347-2018

FDA classification

Class I

Brand / firm

Primus Pharmaceuticals, Inc.

Sold / distributed

Nationwide in the USA.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 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 68040-606-16.