1,463 recalls · Class I, newest first
Reason Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile…
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite…
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Reason Presence of Particulate Matter: particulate matter identified as copper salts
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Reason Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Reason Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper…
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper…
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper…
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper…
Reason Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Reason Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert…
Reason Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert…
Reason Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100…
Reason Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610…
Reason Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610…
Reason Non-Sterility: Product manufactured under non-sterile production conditions.
Reason Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as…
Reason Microbial Contamination of Non-Sterile Product
Reason Microbial Contamination of Non-Sterile Products