Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported February 21, 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.
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…
Primus Pharmaceuticals, Inc. recalled Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus … - a critical-severity action.
Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus … was recalled by Primus Pharmaceuticals, Inc. in February 21, 2018. Reason: Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for …. Check the official notice for the remedy. Verify recall #D-0345-2018 with the FDA Drug before acting.
The recall
Primus Pharmaceuticals, Inc. issued this critical-severity FDA Drug recall-Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for ….
- Critical
- severity level
- Class I
- classification
- February 21, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0345-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0345-2018) was formally reported on February 21, 2018, with the manufacturer initiating the action on January 26, 2018. It is classified under Critical severity (Class I), with a current status of Terminated. Primus Pharmaceuticals, Inc. is listed as the recalling firm, operating out of Scottsdale, AZ. Federal records list the affected scope as 135,277 bottles.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide in the USA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,772 children & baby products recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
135,277 bottles
Related Recalls
6
0 from same agency
Product description
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 Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0345-2018 |
| Date reported | February 21, 2018 |
| Date initiated | January 26, 2018 |
| Recalling firm | Primus Pharmaceuticals, Inc. |
| Firm location | Scottsdale, AZ |
| Affected scope | 135,277 bottles |
| Distribution | Nationwide in the USA. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0345-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Primus Pharmaceuticals, Inc.. Units affected: 135,277 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 21, 2018. Severity: Critical. Recall number: D-0345-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0345-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Children & Baby Products · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
Showing 5 of 4006 other recalls in this category.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 21, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.