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.
- Hazard
- sterilization-defect
- contamination-risk
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.
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