FDA Recalls Neonatal TPN Starter Bag for Lacking Sterility Assurance
Central Admixture Pharmacy Services recalls 68 neonatal TPN starter bags nationwide due to lack of validation data for decontamination cycles, posing a contamination risk.
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 an FDA Class II recall of a sterile injectable product with insufficient validation of sterilization/decontamination processes. Although no illnesses or injuries have been reported, the potential for contamination poses a material risk of harm, particularly for neonatal patients.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Neonatal TPN Starter Bags (250 mL IV bags) containing Amino Acids (trophamine) 3%/Dextrose 5% with low calcium and heparin. The recall affects 68 bags distributed nationwide in the USA.
The manufacturer lacks validation data for decontamination cycles, which means the company cannot assure the product meets sterility requirements. This quality control deficiency is significant for a sterile injectable product intended for neonatal (newborn) patients.
Healthcare providers and patients who have received this product should contact their healthcare provider immediately for guidance on replacement or alternative products.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% 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: 72196-0427-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- 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: 36-252082
- Exp. 7/16/2023
- 36-254925
- 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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