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 Plasma-Lyte/Tromethamine, low potassium, 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, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixtu... 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, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mE... 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, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 ... 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 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL... 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 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL ... 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, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL... 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, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 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, Maintenance 4:1 Plasmalyte, low potassium, low K, packaged in 1047 mL per ... 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 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per b... 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, HIGH POTASSIUM (100 mEq), packaged in 200 mL per bag, Rx only, Central Admi... 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 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 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, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL ... 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, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Adm... 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 Modified del Nido Microplegia, packaged in 40 mL per syringe, 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 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10%, packaged in 250 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 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM, packaged in 250 ... 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 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag,... 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 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM, packaged in 25... 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 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10%, packaged in 250 mL per bag, R...