Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, R...
FDA Drug Recall #D-0346-2018 — Class I — January 26, 2018
Recall Summary
| Recall Number | D-0346-2018 |
| Classification | Class I — Serious risk |
| Date Initiated | January 26, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Primus Pharmaceuticals, Inc. |
| Location | Scottsdale, AZ |
| Product Type | Drugs |
| Quantity | 4,006 bottles |
Product Description
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.
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 Pattern
Nationwide in the USA.
Lot / Code Information
All lots within expiry.
Other Recalls from Primus Pharmaceuticals, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0345-2018 | Class I | Limbrel (flavocoxid 500 mg) capsules, 60-count ... | Jan 26, 2018 |
| D-0344-2018 | Class I | Limbrel (flavocoxid 250 mg) capsules, 60-count ... | Jan 26, 2018 |
| D-0347-2018 | Class I | Limbrel500 (flavocoxid and citrated zinc bisgly... | Jan 26, 2018 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.