The Recall Desk

FDA (Drugs) recall action 83997

Basic Reset Inc. recalled 11 products on 2019-11-13

The FDA (Drugs) publishes a recall like this one as 11 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 11 pages.

Products
11
Announced
2019-11-13
Critical
0
Units
4,004

Why these products were recalled

Marketed without an Approved NDA/ANDA

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.

States named across these recalls

1–11 of 11

  • ModerateFDA (Drugs)··2019-11-13

    Basic Reset CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 598 bottles of CBD Reset 750 True Full Spectrum Cinnamon because the product was marketed without an approved NDA or ANDA.

    Product
    Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2019-11-13

    Basic Reset CBD Product Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 98 bottles of CBD Reset 750 because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··2019-11-13

    Biogenyx CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 25 bottles of Biogenyx CBD Oil because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2019-11-13

    Basic Reset CBD Product Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 391 bottles of CBD Reset 2400 because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2019-11-13

    Biogenyx CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling Biogenyx CBD Oil because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2019-11-13

    Biogenyx CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling Biogenyx CBD Oil because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2019-11-13

    Basic Reset Recalls Miracle Facelift Masque for Lack of FDA Approval

    Basic Reset Inc. is recalling Miracle Facelift Masque because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2019-11-13

    Basic Reset Nuovi Skin Toner Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 1,000 bottles of Nuovi Skin Toner because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2019-11-13

    Basic Reset Recalls Nuovi Firming Masque for Lack of FDA Approval

    Basic Reset Inc. is recalling 339 bottles of Nuovi Firming Masque because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively for Basic Reset 260 W. Main St., Ste 103 Hendersonville, TN 37075
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2019-11-13

    Basic Reset Earth Wash Cleaner Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 949 bottles of Earth Wash Cleaner because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075.
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2019-11-13

    Basic Reset CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 554 bottles of CBD Reset 750 oil because the product was marketed without an approved FDA application.

    Product
    Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Distribution
    2 states