2,661 recalls, newest first
Reason Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Reason Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Defective container; blister packaging inadequately sealed.
Reason Defective container; blister packaging inadequately sealed.
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Reason Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Reason Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Reason Failed Impurities/Degradation Specifications.
Reason Failed Impurities/Degradation Specifications.
Reason Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Reason Subpotent Drug
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.