1,463 recalls · Class I, newest first
Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Presence of Particulate Matter: particulate matter identified as copper salts
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Non-Sterility: Product manufactured under non-sterile production conditions.
Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Microbial Contamination of Non-Sterile Product
Microbial Contamination of Non-Sterile Products