FDA-Drug2023-08-09Class II

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1

Hazard

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Sold states
Nationwide in the USA
Affected count
356 bags
Manufactured in
2200 S 43rd Ave, N/A, Phoenix, AZ, United States
Products
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0997-2023

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