# FDA recall D-0347-2018

> **Primus Pharmaceuticals, Inc.** · Class I · drug recall initiated 2018-01-26.

## Product

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.

## 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.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0347-2018
- **Recalling firm:** Primus Pharmaceuticals, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-26
- **Report date:** 2018-02-21
- **Termination date:** 2019-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Scottsdale, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0347-2018

## Citation

> AI Analytics. FDA recall D-0347-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0347-2018. Source: US FDA. Licensed CC0.

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