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.
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
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