Neonatal TPN Starter Bags Recalled for Sterility Assurance Gaps
Central Admixture Pharmacy Services is recalling 140 bags of Neonatal TPN Starter Bag due to lack of validation data for sanitization cycles. The injectable nutrition product was 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 a Class II FDA recall of an injectable parenteral nutrition product for neonates. While no illnesses have been reported, the lack of validation for sanitization cycles creates significant risk of contamination in a high-risk patient population, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 140 bags of Neonatal TPN Starter Bag (Amino Acids 3%/Dextrose 10% with Calcium and Heparin) distributed nationwide. The affected product is an intravenous nutrition formula supplied in 250 mL bags, intended for neonatal patients.
The recall was initiated because the manufacturer determined that the sanitization cycles used in production lack adequate validation data. This means the effectiveness of the sterilization process cannot be assured, creating a potential risk of bacterial or microbial contamination in the final product.
The affected lot numbers are 36-260019 and 36-260023, with an expiration date of August 19, 2023.
Healthcare providers and institutions should immediately stop using these lots and contact Central Admixture Pharmacy Services for further instructions. Patients who received this product should contact their healthcare provider.
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 — Intravenous Nutrition
- Affected units
- 140
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 (3)
- Lot# 36-260019
- 36-260023
- Exp 8/19/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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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