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, 25 mg/250 mL* (100 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 30 mmole added to 0.9% sodium chloride 500 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 EPINEPHrine added to dextrose 5%, 4 mg/250 mL* (16 mcg/mL), 250 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 EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 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 heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx o... 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, 5,000 units/500 mL* (10 units/mL), 500 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 PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 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 NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 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 phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 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, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Ce... 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 diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive 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 diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive 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 heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/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 oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Se... 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 tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 S... 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 EPINEPHrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Cen... 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 added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 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 NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 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 NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 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 heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only,...