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Recall Of Drugs, Dietary Supplements And Devices By Basic Reset And Biogenyx

January 23, 2020,

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

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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