Neonatal TPN Starter Bags Recalled Due to Sterility Validation Deficiency
Central Admixture Pharmacy Services is recalling 80 bags of Neonatal TPN Starter Bag nationwide due to insufficient sterility assurance. The deficiency stems from lacking 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 with no reported illnesses or injuries. Per the rubric, Class II recalls where the hazard is theoretical rather than confirmed align with a High severity rating.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 80 bags of Neonatal TPN Starter Bag (Amino Acids 2.5%/Dextrose 10%, 250mL IV bag, NDC 72196-0402-1). The affected lot is 36-254910, expiring July 2023. The product was distributed nationwide in the United States.
The recall is due to lack of assurance of sterility. Validation data for decontamination cycles is lacking, which creates a deficiency in manufacturing process controls for this sterile parenteral product. This is classified as an FDA Class II recall.
This product is a prescription parenteral nutrition formulation used for neonatal patients. The manufacturer is Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, Arizona 85043.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0402-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Hazard
- Affected units
- 80
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: 36-254910
- 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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