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Recall Observatory FDA recall evidence

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.