Drug product

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.

D-0345-2018

January 26, 2018

Class I

Product summary

Firm: Primus Pharmaceuticals, Inc.
Event: Event 79055
Status: Terminated
Classification: Class I
Quantity: 135,277 bottles
Official record key: drug-enforcement:D-0345-2018

Official wording

Reason: 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.

Code information: All lots within expiry.

Distribution pattern: Nationwide in the USA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.