Reported Feb 21, 2018 · Terminated

Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured…

Primus Pharmaceuticals, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Primus Pharmaceuticals, Inc. · 7373 N. Scottsdale Rd., Suite B-200 · Scottsdale, AZ · 85253

Is this the product you have?

  • Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only
  • Manufactured forPrimus Pharmaceuticals, Inc., Scottsdale, AZ 85253
  • Manufactured byCornerstone Research and Development, Ogden, UT 84404, NDC 68040-606-16
Lot codes and dates
  • All lots within expiry.
Amount recalled
160,489 bottles

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 16, 2019 · Data as of Sep 19, 5:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.