Neonatal TPN Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 68 bags of Neonatal TPN Starter Bag due to lack of assurance of sterility and missing validation data for decontamination cycles.
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 affecting high-risk injectable neonatal medication. The recall addresses a confirmed process deficiency (lack of sterility assurance validation) without reported illnesses or injuries, meeting the rubric criterion for high-risk injectable products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 68 bags of Neonatal TPN Starter Bag (Trophamine 2%/Dextrose 5% with Calcium and Heparin), NDC 72196-0415-1, distributed nationwide. This product is an intravenous nutrition preparation intended for neonatal patients.
The recall is due to lack of assurance of sterility. The manufacturer lacks validation data for the decontamination cycles used in the manufacturing process, which creates a risk that the product may not be sterile.
The affected lots are 36-251453 (expires 7/14/2023) and 36-252361 (expires 7/17/2023). Healthcare providers and hospitals should not use these specific lots and should contact Central Admixture Pharmacy Services, Inc. for instructions on return or disposal.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0415-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous Nutrition
- Affected units
- 68
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: 36-251453
- Exp. 7/14/2023
- 36-252361
- Exp. 7/17/2023.
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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