FDA Drug recall D-0344-2018
Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253
- FDA Drug
- Class I
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class I recall of Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253 by Primus Pharmaceuticals, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0344-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-01-26 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Primus Pharmaceuticals |
| Distribution | US |
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
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.
Identifiers
| code_info | All lots within expiry. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0344-2018%22
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