Drug recall: Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc.…
Class I FDA enforcement event 79055. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Primus Pharmaceuticals, Inc. started this drug recall on 26 Jan 2018. The firm address in the FDA record is in Scottsdale, AZ. FDA put the recall in Class I. FDA event 79055 has 4 product records. The first FDA enforcement report date is 21 Feb 2018. The record gives the status Terminated, with the termination date 16 Jul 2019.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in the USA.
Recalling firm
Primus Pharmaceuticals, Inc., Scottsdale, AZ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0344-2018 | 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. | 7,826 bottles | Class I | Terminated | 21 Feb 2018 |
| D-0345-2018 | 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. | 135,277 bottles | Class I | Terminated | 21 Feb 2018 |
| D-0346-2018 | Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 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 68040-605-16. | 4,006 bottles | Class I | Terminated | 21 Feb 2018 |
| D-0347-2018 | 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. | 160,489 bottles | Class I | Terminated | 21 Feb 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2018
- 367
- Share of these events in Class I
- 11%
- Product records in this event
- 4
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0344-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 79055. https://recallregister.com/fda/i/79055/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in the USA.
- What quantity of product is in FDA event 79055?
- The event has 4 product records. The first record gives this quantity:
7,826 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2018 have the same class?
- 11% of the 367 drug events that started in 2018 are in Class I.