Neonatal TPN Starter Bags Recalled Due to Sterility Validation Failure
Central Admixture Pharmacy Services is recalling 356 neonatal TPN starter bags due to lack of validation data for decontamination cycles. The sterility of the affected lots cannot be assured.
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 involving a sterility assurance failure for a critical neonatal parenteral medication product. Although no illnesses or injuries are reported, the theoretical risk of contamination in a product designed for vulnerable neonatal patients constitutes a risk-of-harm scenario meeting the High severity criterion.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 356 neonatal TPN (Total Parenteral Nutrition) Starter Bags. The recalled product contains Trophamine 3% Amino Acids and Dextrose 10% in 250 mL IV bags. The manufacturer is located at 2200 South 43rd Avenue, Phoenix, Arizona 85043.
The recall is due to lack of assurance of sterility. The validation data for decontamination cycles is lacking, meaning the sterility of the affected product cannot be confirmed. The affected lots are Lot 36-251326 (Expiration 7/13/2023), Lot 36-251451 (Expiration 7/14/2023), and Lot 36-254915 (Expiration 7/22/2023).
The product was distributed nationwide throughout the United States. This is a prescription-only medication intended for neonatal patients requiring parenteral nutrition support.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 356
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 (6)
- Lot: 36-251326
- Exp. 7/13/2023
- 36-251451
- Exp. 7/14/2023
- 36-254915
- 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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