The Recall Desk

FDA (Drugs) recall action 87283

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalled 2 products on 2021-03-24

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2021-03-24
Critical
0
Units
47

Why these products were recalled

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.

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.

1–2 of 2

  • SevereFDA (Drugs)··2021-03-24

    Spironolactone Tablets Recalled Due to Potential Labeling Error

    Bryant Ranch Prepack is recalling 35 bottles of Spironolactone 25 mg tablets because they may contain 50 mg tablets.

    Product
    Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch P
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-03-24

    Spironolactone Tablets Recalled Due to Potential Labeling Mix-Up

    Bryant Ranch Prepack is recalling 12 bottles of Spironolactone 50 mg tablets because they may contain 25 mg tablets due to a labeling error.

    Product
    Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01
    Category
    Distribution
    0 states