Neonatal TPN Starter Bags Recalled for Insufficient Sterilization Validation
Central Admixture Pharmacy Services is recalling 136 neonatal TPN starter bags due to lack of validated sterilization cycles. The recall affects bags distributed nationwide with lot numbers 36-262160 and 36-262146.
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 a critical neonatal injectable product. The hazard—lack of validated sterilization procedures leading to unassured sterility—represents a theoretical contamination risk. No illnesses, injuries, or confirmed contamination incidents are reported in the source material, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' which yields High severity.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Neonatal TPN Starter Bags due to lack of validation data for sanitization cycles. The affected product is a 250 mL IV bag containing amino acids (trophamine) 3%, dextrose 10%, low calcium, and heparin, distributed nationwide for neonatal nutritional support.
The recall involves 136 bags with lot numbers 36-262160 and 36-262146, with an expiration date of 8/21/2023 (NDC 72196-0428-1). The lack of validated sterilization procedures means the sterility of the bags cannot be assured, creating a potential contamination risk.
Patients and healthcare providers who have the recalled bags should contact Central Admixture Pharmacy Services or the FDA regarding any adverse events.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/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: 72196-0428-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Affected units
- 136
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 (3)
- Lot# 36-262160
- 36-262146
- Exp 8/21/2023
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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