Class II Recall

Central Admixture Pharmacy Services, Inc.

Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043,NDC: 72196-0407-1
Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Classification
Class II
Status
Terminated
Lot
Lot: 36-251206, Exp. 7/10/2023.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.