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.
Reported: February 21, 2018 Initiated: January 26, 2018 #D-0346-2018
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.
Details
- Recalling Firm
- Primus Pharmaceuticals, Inc.
- Units Affected
- 4,006 bottles
- Distribution
- Nationwide in the USA.
- Location
- Scottsdale, AZ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Primus Pharmaceuticals, Inc.. Units affected: 4,006 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 21, 2018. Severity: Critical. Recall number: D-0346-2018.
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