Class II · Moderate risk
Age Stop Ex
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Unapproved or misbranded drugs
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified.
309 FDA drug recalls with this cause, newest first.
Every prescription drug and most over-the-counter drugs sold in the US need either an approved application (an NDA or ANDA) or must fit an OTC monograph. A product that skips both is pulled regardless of whether anything is physically wrong with it, because its dose, purity and claims were never checked. Typical cases: compounded products sold at commercial scale, imported drugs not cleared for the US, and products whose labeling makes claims that turn them into unapproved new drugs. Supplements that turn out to contain a hidden prescription drug are filed under chemical contamination and hidden ingredients instead.
Class II · Moderate risk
Age Back
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Acne Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Acne Cystic
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Acupuncture
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Kushim Tablets
Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Class I · High risk
Panther Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Rhino 7 Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Stallion Platinum 30000 Capsules in blue
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Bull Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Cinnamon
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Natural Flavor
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Wintergreen
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 2400
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz.
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Cinnamon
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Nuovi Firming Masque
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset Nuovi Skin Toner
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Miracle Facelift Masque
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset Earth Wash Cleaner and Personal Care
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Entropic Labs SARM RAD-140
Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
Class II · Moderate risk
LA FRESH travel lite Sunnyside Lotion Wipe silky
Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.
Class III · Low risk
ATHLETICARE Anti-Bacterial Hand Soap AC 550
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
Class II · Moderate risk
Life-Line tm Catalytic Activated Energy Water
Unapproved new drug
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