Neonatal TPN Starter Bags Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 108 Neonatal TPN Starter Bags (Lot 36-256338) due to lack of assurance of sterility and insufficient 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: Class II recall of a neonatal IV medication with lack of sterility assurance and insufficient decontamination validation data. No illnesses or injuries reported; hazard is theoretical but significant for this high-risk product category.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 108 Neonatal TPN Starter Bags (Amino Acids 3.5% / Dextrose 10%, 250 mL IV bags) distributed nationwide. The recall is due to lack of assurance of sterility and insufficient validation data for decontamination cycles.
The affected lot (36-256338, expiration 7/29/2023) is an Rx-only product. The firm identified that validation data for the decontamination cycles is lacking, which raises concerns about sterility assurance for this neonatal intravenous medication.
Healthcare providers who received this product should stop use and contact the manufacturer or FDA with any questions or if any adverse events occur.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- Affected units
- 108
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: 36-256338
- Exp. 7/29/2023.
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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