💊 Drugs • 12,141 recalls
Airgas Medical Services
Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Sandoz Incorporated
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Airgas Medical Services
Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder.
Fabscout Entertainment
Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Healthy Life Chemistry Inc
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.
Bethel Nutritional Consulting
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.
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Zi Xiu Tang Success
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Bethel Nutritional Consulting
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.
Zi Xiu Tang Success
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Fresenius Kabi USA
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Healthy Life Chemistry Inc
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.
Fabscout Entertainment
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
Fabscout Entertainment
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.