Neonatal TPN Bags Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 516 Neonatal TPN Starter Bags due to insufficient validation of decontamination processes. The recall affects bags distributed nationwide.
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 parenteral nutrition for neonates. The hazard is lack of sterility assurance due to insufficient validation of decontamination cycles—a theoretical but serious risk-of-harm in a vulnerable patient population. No illnesses or injuries have been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 516 Neonatal TPN (Total Parenteral Nutrition) Starter Bags, 250 mL IV bags containing Amino Acids (trophamine) 3%, Dextrose 10%, calcium, and heparin. The product is distributed nationwide and is intended for intravenous use in neonatal patients. Affected lot numbers include: 36-251200, 36-251209 (expiring 7/10/2023); 36-252140 (expiring 7/16/2023); and 36-256334, 36-256335 (expiring 7/29/2023).
The recall is issued because validation data for decontamination cycles is lacking, which creates a lack of assurance of sterility. Without documented validation of decontamination processes, the manufacturer cannot confirm that the product meets required sterility standards.
Neonates receiving parenteral nutrition are a vulnerable population. Although no illnesses or injuries have been reported to date, the potential for contamination poses a serious risk to patients who would receive this product.
Healthcare facilities should immediately stop using product from the affected lots and contact the manufacturer regarding return procedures. Patients who may have received product from the recalled lots should be monitored for signs of infection or other complications.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Affected units
- 516
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 (8)
- Lot: 36-251200
- 36-251209
- Exp. 7/10/2023
- 36-252140
- Exp. 7/16/2023
- 36-256334
- 36-256335
- 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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