The Recall Desk

FDA (Drugs) recall action 79055

Primus Pharmaceuticals, Inc. recalled 4 products on 2018-02-21

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2018-02-21
Critical
0
Units
307,598

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • SevereFDA (Drugs)··2018-02-21

    Primus Pharmaceuticals Recalls Unapproved Limbrel Flavocoxid Capsules Nationwide

    Primus Pharmaceuticals is recalling Limbrel (flavocoxid 500 mg) capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    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.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-02-21

    FDA Recalls Unapproved Limbrel500 Capsules Marketed Without Approval

    Primus Pharmaceuticals is recalling Limbrel500 capsules because they were marketed without FDA approval, meaning their safety and efficacy have not been established.

    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.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-02-21

    Primus Pharmaceuticals Recalls Unapproved Limbrel250 Capsules Nationwide

    Primus Pharmaceuticals is recalling 4,006 bottles of Limbrel250 capsules because the product was marketed without an approved NDA or ANDA, meaning its safety and efficacy have not been established.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-02-21

    FDA Recalls Unapproved Limbrel Flavocoxid Capsules Nationwide

    Primus Pharmaceuticals is recalling 7,826 bottles of Limbrel (flavocoxid 250 mg) capsules because the product was marketed without an approved NDA or ANDA.

    Product
    Limbrel (flavocoxid 250 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 68040-601-16.
    Category
    Distribution
    0 states