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 oxyTOCIN 30 units added to Lactated Ringer's 500 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 oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharma... 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 oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Phar... 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 oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharma... 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 oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Phar... 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 dilTIAZem added to dextrose 5%, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixt... 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 dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Centr... 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 norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 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 PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, ... 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 potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admix... 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 vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Cent... 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 vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Cent... 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 vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admix... 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 vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Cent... 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 vancomycin added to dextrose 5%, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixt... 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 vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Centr... 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 vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 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 PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only,... 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 vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Centr... 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 heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx ...