Neonatal TPN IV bags recalled due to sterility validation deficiency
Central Admixture Pharmacy Services is recalling 24 neonatal TPN IV bags due to lack of sterility assurance. Validation data for decontamination cycles is lacking, preventing confirmation that units are sterile.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 of an IV pharmaceutical for a vulnerable neonatal population with serious sterility assurance deficiency. No illnesses or injuries reported in source; the hazard is theoretical based on lacking validation data.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 24 units of its Neonatal TPN Starter Bag (250 mL IV bag containing Amino Acids 2% / Dextrose 10% with low calcium and heparin, NDC 72196-0425-1, Lot 36-254923, Exp. 7/22/2023). The affected units were distributed nationwide in the United States.
The company initiated this recall due to lack of assurance of sterility. Validation data for the decontamination cycles is lacking, which means the company cannot confirm these units are sterile.
This is a prescription-only neonatal intravenous nutrition product. Healthcare providers and facilities that received this product should contact the manufacturer for recall instructions.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/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: 72196-0425-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 24
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: 36-254923
- 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.
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