Neonatal TPN Starter Bag recalled for sterility assurance concerns
Central Admixture Pharmacy Services is recalling a neonatal TPN bag due to lack of validated sanitation cycles, affecting 84 units distributed nationwide.
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: FDA Class II recall with no reported illnesses or injuries. The hazard stems from lack of validated sterilization data rather than confirmed contamination, making this a theoretical risk to sterility assurance. Per the rubric, theoretical hazards without reported harm are scored at most 3.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling one lot of Neonatal TPN Starter Bag (Amino Acids 2.5%/Dextrose 10% with Calcium and Heparin, 250mL, NDC 72196-0418-1) because validation data for sanitization cycles is lacking. Without proper validation of sterilization processes, there is no assurance that the product maintains adequate sterility.
The recalled lot (36-260015, expiration 8/19/2023) consists of 84 bags distributed nationwide. This product is a prescription compounded medication used for neonatal intravenous nutrition support.
Healthcare facilities and healthcare providers who received this product should stop using it and contact Central Admixture Pharmacy Services, Inc. at 2200 South 43rd Avenue, Phoenix, AZ 85043, for instructions on product disposition and alternatives. Patients or caregivers should not attempt to use these bags and should inform their healthcare provider if they have questions about their current treatment.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- Affected units
- 84
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 (2)
- Lot# 36-260015
- Exp 8/19/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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.
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