Class II · Moderate risk Terminated
Cardioplegia Solution
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
FDA Drug Recalls
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Class II · Moderate risk Terminated
Cardioplegia Solution
Reason 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 Terminated
Cardioplegia Solution
Reason 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 Terminated
Microplegia
Reason 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 Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Gabapentin Tablets
Reason Product mixup: one foreign tablet found in product.
Class I · High risk Terminated
G-Supress DX
Reason Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Class II · Moderate risk Terminated
Fyremadel
Reason Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Class III · Low risk Terminated
Avicel DG
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH-200 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH-102 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH-101 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL
Reason Subpotent Drug: Out of specification results for low potency was obtained.
Class II · Moderate risk Terminated
Simvastatin USP 40 mg
Reason CGMP deviations.
Class II · Moderate risk Terminated
Simvastatin USP 20 mg
Reason CGMP deviations.
Class II · Moderate risk Terminated
Glimepiride USP
Reason CGMP deviations.
Class II · Moderate risk Terminated
Simvastatin USP
Reason CGMP deviations.
Class II · Moderate risk Terminated
Montelukast Sodium USP
Reason CGMP deviations.
Class III · Low risk Terminated
Norepinephrine Bitartrate Injection
Reason Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Class III · Low risk Terminated
Dodex Injectable Cyanocobalamin Injection
Reason Sub-potent drug: assay test result below specifications at 9-month timepoint.
Class I · High risk Terminated
SOFT HANDS Alcohol Antiseptic 80%
Reason Chemical Contamination: FDA testing found Presence of methanol