Class II · Moderate risk
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
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
Dermamedics Calm & Correct Cream in 2 oz. containers with SKU…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Dermamedics Post Procedure Cream
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
HydrOXYzine HCI Tablets USP 50 mg
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class II · Moderate risk
HydrOXYzine HCI Tablets USP 25 mg
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class II · Moderate risk
HydrOXYzine HCI Tablets USP 10 mg
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class I · High risk
Virilis Pro
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Class I · High risk
PHUK Sexual Enhancement Ultimate Pleasure
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Class I · High risk
Prolifta Dietary Supplement Prolifta
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Class II · Moderate risk
Aldactone (spironolactone)
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Class II · Moderate risk
Spironolactone tablets
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Class II · Moderate risk
Spironolactone tablets
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Class I · High risk
METHA-DROL Extreme capsules
Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug
Class I · High risk
Super-DMZ Rx 2.0 Capsules
Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug
Class I · High risk
B-50 capsules
Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug
Class II · Moderate risk
INK-EEZE Tattoo Black Label Numbing Spray
Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.
Class II · Moderate risk
INK-EEZE Tattoo Numbing Spray
Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.
Class II · Moderate risk
HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30…
Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)
Class II · Moderate risk
Cornea Coat
Marketed without an Approved NDA/ANDA.
Class II · Moderate risk
Oxiracetam & Choline
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
BoostYourGrade.com
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Brain Defogger
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Piracetam & Choline
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Aniracetam and Choline
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Nootropa Cognitive Enhancement Supplement
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
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