FDA-Drug2023-09-06Class II

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1

Central Admixture Pharmacy Services, Inc.
Hazard

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Sold states
Nationwide in the USA
Affected count
104 bags
Manufactured in
2200 S 43rd Ave, N/A, Phoenix, AZ, United States
Products
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1117-2023

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