1,463 recalls · Class I, newest first
Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
Marketed Without an Approved ANDA/NDA: presence of sibutramine
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
Marketed Without an Approved ANDA/NDA: presence of sildenafil
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Labeling: Label Mix up; product labeled did not indicated Extended Release
Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.