Neonatal TPN IV Bags Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 92 bags of neonatal TPN IV bags (lot 36-262161) because of inadequate validation of manufacturing sanitization processes. The affected product was distributed nationwide.
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 classification with lack of sterility assurance in a neonatal IV product. No illnesses or injuries reported. Score reflects high risk-of-harm potential for vulnerable neonatal patients without documented adverse events.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 92 bags of Neonatal TPN Starter Bag (Amino Acids [trophamine] 3.5%/Dextrose 10% with Heparin) in 250-milliliter IV bags. The affected lot is 36-262161 with expiration date 8/21/2023. This product is used for intravenous nutrition in neonatal patients.
The recall was issued due to lack of assurance of sterility. The manufacturer lacks validation data for sanitization cycles, meaning there is no documented evidence that the manufacturing environment met required sterility standards. This creates a potential risk of microbial contamination of the product.
The affected lot was distributed nationwide in the United States. Healthcare facilities and practitioners that received this product are advised to stop using it and contact the manufacturer for replacement or return instructions.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Affected units
- 92
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# 36-262161
- 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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