Neonatal TPN IV Bags Recalled Over Sterility Assurance Failures
Central Admixture Pharmacy Services is recalling 304 neonatal TPN IV starter bags nationwide due to lack of sterility assurance and insufficient validation of decontamination processes. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—insufficient assurance of sterility on a neonatal intravenous product—constitutes a risk-of-harm scenario for vulnerable populations where injury has not yet been reported, meeting the Score 3 criterion.
Plain-English summary
Central Admixture Pharmacy Services, Inc. (Phoenix, Arizona) is recalling 304 units of Neonatal TPN Starter Bags. Each unit is an intravenous bag containing Amino Acids 3.5%, Dextrose 10%, low calcium, and heparin, with a total volume of 250 mL (NDC 72196-0429-1). The affected lot numbers are 36-251203 (expiration 7/10/2023) and 36-254924 (expiration 7/22/2023). These products were distributed nationwide.
The recall was initiated because of insufficient assurance of product sterility. The manufacturer lacks validation data for the decontamination cycles used during manufacturing, which means the sterilization process cannot be confirmed to meet required standards.
No illnesses or injuries have been reported. Healthcare facilities, pharmacies, and other entities with affected inventory are advised to contact the manufacturer for guidance regarding the recalled products.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 304
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: 36-251203
- Exp. 7/10/2023
- 36-254924
- Exp. 7/22/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 95 products in this recall →Related recalls
Same manufacturer · Central Admixture Pharmacy Services, Inc.
See all →- ModeratePediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
- SeverePediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
- SevereInjectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
- HighInjectable Lidocaine Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighMidazolam Injectable Solution Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2023-10-11
Same hazard · sterilization defect
See all →- SevereMedline Convenience Kits recalled for potential sterility assurance defects
FDA (Devices) · 2026-05-13
- ModerateMedline Burn Care Kits Recalled Due to Sterilization Calibration Issues
FDA (Devices) · 2026-05-13
- HighMedline PPE Kit recalled for sterilization calibration issues
FDA (Devices) · 2026-05-13
- SevereMedline Convenience Kits recalled for potential sterilization issues
FDA (Devices) · 2026-05-13
- HighMedline Convenience Kits recalled due to sterilization equipment calibration issues
FDA (Devices) · 2026-05-13