Hard Ten Days
Reason Marketed Without An Approved NDA/ANDA
1,739 recalls · Class I, newest first
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA
Reason Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
Reason Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Reason Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Reason Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Reason Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Reason Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Reason Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
Reason Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.