Class II · Moderate risk
Herpes Soap
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
Herpes Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Herpes-G
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Hernia Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Hair Back Lotion
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Hair Back Ex
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Fungo Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Fungo Lotion
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Fungo Balm
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Fungo Balm
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Flare Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Fire Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Edema Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Dragon Pain Balm
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Detoxin-S
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Detoxin Ex
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
DeTensin Ex
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Dermatoxin
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Dermamycin
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
De-Fibroidin
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Cellulite Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Blood Clot Purger
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Bleeding Stop
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Asthma Chest Rub
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Asma Stopper
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
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