D-0997-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2023
- Initiation Date
- July 14, 2023
- Termination Date
- March 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 356 bags
Product Description
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
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 36-251326, Exp. 7/13/2023; 36-251451, Exp. 7/14/2023; 36-254915, Exp. 7/22/2023.