Class II · Moderate risk
ParaGard T 380A - Intrauterine Copper Contraceptive
Non-sterility: due to a failed sterility test
FDA Drug Recalls
362 recalls, newest first
Class II · Moderate risk
Zoledronic Acid Injection 5 mg per 100 mL
Lack of Assurance of Sterility; leaking of premix bags
Class II · Moderate risk
All sterile drugs compounded between 2/21/14 and 2/24/14.
Lack of Assurance of Sterility: All compounded products.
Class I · High risk
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.
Class II · Moderate risk
ROHTO Redness Relief
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Cooling Eye Drops
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Dry Eye
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Redness Relief
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Redness Relief
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
Heparin Sodium 2000 USP Heparin Units per 1000 mL
Lack of Assurance of Sterility; potential leakage from administrative port.
Class II · Moderate risk
Aminosyn 3.5% M Sulfite-Free
Lack of Assurance of Sterility; potential leakage from administrative port.