Recall Of Drugs, Dietary Supplements By Basic Reset And Biogenyx – NAFDAC

The National Agency for Food and Drug Administration and Control has been informed by the U.S Food and Drug Administration (FDA) of a recall of 25 drugs by basic reset and biogenyx of Hendersonville, Tennessee due to consent decree for federal violations and unlawfully distribution of dietary supplements that are adulterated and misbranded.

Basic Reset and Biogenyx have not received the FDA’s approval for the sale of their drugs and one device, despite the companies’ claims that these products can be used to diagnose, cure, mitigate, treat or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain. Consumer use of an unapproved product that claims to treat diseases may cause them to delay seeking appropriate medical care. Additionally, unapproved products have not been reviewed by the FDA for quality, safety or effectiveness.

The list of basic reset and biogenyx products recalled includes:

S/NPRODUCTS AND PRODUCT DETAILS
1Nuovi Skin Toner, Refined Ionyte, 4 fl. oz., 118.3 mL bottle.
2Nuovi Firming Masque, Renew and Reset, 2 fl. oz., 59 mL bottle.
3Bee Gold, 8oz. pkg./plastic pouch, SKU: 100-4C.
4Beta Factor, DIETARY SUPPLEMENT 60 capsules per plastic bottle, SKU: 100-4F.
5Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle.
6BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz., (30 mL) bottle, 2400 mg.
S/NPRODUCTS AND PRODUCT DETAILS
7Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle.
8Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg.
9CBDBIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle.
10Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle.
11BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg.
12Dino-Min, 60 capsules per plastic bottle, SKU 100-1C.
13Earth Wash, Cleaner and Personal Care, Eco Friendly, 2 fl. oz. bottle.
14Ionyte, 4 fl. oz. plastic bottle, SKU: 100-1B.
15Mello-Tonin, 2 fl. oz. glass bottle, SKU: 100-5C.
16pH-FX, 4 fl. oz. plastic bottle, SKU: 100-1A.
17SlimUp, 60 capsules per plastic bottle, SKU: 100-5B.
18AquaLyte, 30g pkg./foil pouch, SKU: 1023.
19Body Mass Reset, 4 fl. oz. plastic bottle, SKU: 100-8C.
20GH-C, 60 capsules per plastic bottle, SKU: 100-4F.
21Q-min, 50 capsules per plastic bottle, SKU: 100-9B.
22TrimUp, DIETARY SUPPLEMENT 80 capsules per plastic bottle, SKU: 100-5A.
23Vibrant Energy Drink Singles, 15 g foil pouches (15 pack case) 100-4A and 100-4B.
24Vibrant Energy Drink Canister, 450 g plastic canister 100-4A.
25Energy FX: original Aluminum (100-3A) and sleek (adult and kid & pet) (100-3B).

Healthcare providers and patients in possession of the affected products should immediately stop the administration and use of the products.

Healthcare providers and patients are encouraged to report adverse events associated with the use of these medical devices to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via [email protected]