Class II · Moderate risk
Skin Lift
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
Skin De-Tag
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Skin Cleanser
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Reman-AP
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Reman-8
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Reman-6
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Purple Gold Balm
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Purple Gold Balm
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Pimples Off Solution 60 ML
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Phlegm Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
PC Shrinker
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Pain Stopper
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Pain Away
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
New Life
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Nasal Ez
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Metabolic Booster. 500mg Capsules
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Max Slim
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Lupus Care
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Lump Shrinker
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Lipidtrol
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Immune-2100
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Herpes-P
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
Herpes V Balm
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Herpes V Balm
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
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