Why it was 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.
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.
Lot numbers, UPCs & expiration codes
All lots within expiry.
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0345-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 26, 2018
- FDA report date
- Feb 21, 2018
- Quantity
- 135,277 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Primus Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0345-2018, exactly as published.
Show all FDA fields
- City
- Scottsdale
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 79055
- Address
- 7373 N. Scottsdale Rd., Suite B-200
- Code information
- All lots within expiry.
- Postal code
- 85253
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0345-2018
- Classification
- Class I
- Recalling firm
- Primus Pharmaceuticals, Inc.
- Product quantity
- 135,277 bottles
- Termination date
- Jul 16, 2019
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jan 26, 2018
- Initial firm notification
- Press Release
- Center classification date
- Feb 9, 2018