Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 124 neonatal TPN starter bags nationwide due to lack of sterility assurance from missing decontamination validation data.
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: This is a Class II recall of a parenteral medication due to lack of sterility assurance. No illnesses or injuries have been reported. The hazard is based on insufficient validation data rather than confirmed contamination, fitting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 124 bags of Neonatal TPN Starter Bag (Amino Acids [Trophamine] 3.5%/Dextrose 10% with Calcium and Heparin, 250 mL) distributed nationwide in the USA. The recall was initiated because validation data for decontamination cycles is lacking, resulting in lack of assurance of sterility.
Affected lot numbers are 36-254913 (expiration 7/22/2023) and 36-256706 (expiration 7/30/2023). This is a prescription intravenous medication formulated for neonatal patients. Without proper sterilization validation, the product cannot be confirmed to meet sterility requirements.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0421-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Affected units
- 124
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: 36-254913
- Exp. 7/22/2023
- 36-256706
- 7/30/2023.
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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