FDA Recall D-0347-2018
Primus Pharmaceuticals, Inc. · Scottsdale, AZ
Class I — life-threatening Terminated 536 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0347-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA.
- Recall initiated
- 2018-01-26
- Classified by FDA Center
- 2018-02-09
- FDA published
- 2018-02-21
- Terminated
- 2019-07-16
- Recalling firm
- Primus Pharmaceuticals, Inc.
- Firm location
- Scottsdale, AZ