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 5% with CALCIUM, packaged in 250 m... 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% with CALCIUM and HEPARIN, pack... 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) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, pa... 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 5% with CALCIUM and HEPARIN, packa... 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 and HEPARIN, pack... 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 and HEPARIN, pa... 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% with CALCIUM and HEPARIN, pack... 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) 6%/Dextrose 10% with CALCIUM and HEPARIN, pack... 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% with low calcium and HEPARIN, ... 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 5% with low calcium and HEPARIN, 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 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with low calcium and HEPARIN, ... 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 PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN,... 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) 6%/Dextrose 10% with low calcium and HEPARIN, ... 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) 4.5%/Dextrose 10% with HEPARIN, 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 EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/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 oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 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 oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 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 oxyTOCIN 10 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 Lactated Ringer's 250 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 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmac...