Limbrel — Class I drug recall D-0344-2018
Terminated recall by Primus Pharmaceuticals, Inc., reported 2018-02-21, distributed nationwide. Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for w
| Recall number | D-0344-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Primus Pharmaceuticals, Inc., Scottsdale, AZ, United States |
| Recall initiated | 2018-01-26 |
| Classified | 2018-02-09 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2019-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 7,826 bottles |
| Reason classes | labeling, unapproved product |
| NDC | 68040-0601-16 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0344-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.