112 recalls · Class I, newest first
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.
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.
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Presence of Particulate Matter; Glass particulates observed in vials
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit Male Enhancement product was found to contain two undeclared active pharmaceutical ingredients: sildenafil and tadalafil.
Non Sterility: Microbial contamination
Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug.
Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this product found it to contain undeclared steroid-like substances making it an unapproved new drug.
Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.
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
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
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
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.