Levothyroxine Sodium Tablets
Subpotent Drug
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Failed Dissolution Specifications
Failed content uniformity specifications.
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Lack of assurance of sterility. The recall is due to potential contamination
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials