Class II · Moderate risk
Transplant Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Microplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Microplegia
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Gabapentin Tablets
Product mixup: one foreign tablet found in product.
Class I · High risk
G-Supress DX
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Class II · Moderate risk
Fyremadel (ganirelix acetate)
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Class III · Low risk
Avicel DG
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-200 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-102 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-101 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL
Subpotent Drug: Out of specification results for low potency was obtained.
Class II · Moderate risk
Simvastatin USP 40 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP 20 mg
CGMP deviations.