Jul 14, 2023 FDA drug enforcement
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volum... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy ... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx ... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central ... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central A... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, R... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx ... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 ... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in ... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central ... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Transplant Solution (Plasma-Lyte A), packaged in 165 mL per bag, Rx only, Central Admixture Pharm... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 mL per bag, Rx on... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 ... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per bag, Rx on... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx on... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx on... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per bag, Rx onl... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in 500 mL p... Apr 28, 2023 FDA drug enforcement
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL...