Home / Recalls / Primus Pharmaceuticals, Inc. / D-0345-2018

D-0345-2018 Class I Terminated

Recalled by Primus Pharmaceuticals, Inc. — Scottsdale, AZ

Recall Details

Product Type
Drugs
Report Date
February 21, 2018
Initiation Date
January 26, 2018
Termination Date
July 16, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
135,277 bottles

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.

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.

Distribution Pattern

Nationwide in the USA.

Code Information

All lots within expiry.

Other recalls by Primus Pharmaceuticals, Inc.

  • D-0344-2018 Class I — Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for (January 26, 2018)
  • D-0347-2018 Class I — Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60 (January 26, 2018)
  • D-0346-2018 Class I — Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 6 (January 26, 2018)