Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume = 250mL, IV Ba...
FDA Recall #D-0995-2023 — Class II — July 14, 2023
Product Description
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0402-1
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
80 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-254910, Exp. 7/22/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated