The Recall Desk

FDA (Drugs) recall action 88847

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalled 2 products on 2021-12-01

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
2021-12-01
Critical
0
Units
693

Why these products were recalled

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

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

  • LowFDA (Drugs)··2021-12-01

    Butalbital, APAP, Caffeine Tablets Missing Schedule III Label

    Bryant Ranch Prepack is recalling Butalbital, APAP, Caffeine 50/325/40 mg tablets in multiple bottle sizes because the controlled substance classification "CIII" is missing from the label.

    Product
    Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2021-12-01

    Butalbital/APAP/Caf Tablets Missing Controlled Substance Label

    Bryant Ranch Prepack is recalling Butalbital, APAP, and Caffeine 50/325/40 mg tablets because the label is missing the controlled substance classification "CIII" required by law.

    Product
    Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged
    Category
    Distribution
    0 states