2,357 recalls · Class II, newest first
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.
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Defective container; blister packaging inadequately sealed.
Defective container; blister packaging inadequately sealed.
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).
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Subpotent Drug
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Marketed Without an Approved NDA/ANDA
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Discoloration; discolored solution from cracked vials