Class II · Moderate risk
CBD Metered Dose Inhaler
Marketed Without an Approved NDA/ANDA
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 I · High risk
kleantouch HAND SANITIZER
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class I · High risk
Klean Touch Hand Sanitizer
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class II · Moderate risk
Cholestene capsules
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
Global Hand Sanitizer with moisturizer
CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk
Global Hand Sanitizer with moisturizer
CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk
Immune Boost with natural strawberry flavor
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Class I · High risk
Leafree Instant Hand Sanitizer Aloe Vera
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Class II · Moderate risk
pH-D Feminine Health Boric Acid Vaginal Suppositories
Marketed without an Approved NDA/ANDA.
Class I · High risk
Volu-Sol Handrub Sanitizing Solution
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Class II · Moderate risk
Thyro-H
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
BioMycin
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Worm Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Voice Rescue
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Vitiligo Off Ointment
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Vigo-XXX
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Vertigo Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Tution 130
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Thyro-Lo
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Sweat Oil
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Sugar Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Stomach Cleanser
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Sperm Booster
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Skin Moist
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Skin Lift Balm
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
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