Neonatal Intravenous Nutrition Bags Recalled for Insufficient Sterility Validation
Central Admixture Pharmacy Services recalled 40 bags of Neonatal TPN starter bags due to lack of validation data for sanitization cycles. This creates a potential sterility assurance gap for an intravenous medication used for newborns.
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 a sterile intravenous neonatal medication due to insufficient validation of sterilization processes. Although no illnesses or injuries have been reported and the potential hazard is theoretical (unconfirmed sterility gap rather than confirmed contamination), the risk-of-harm nature of the product and vulnerability of the patient population support a High severity rating per the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. has recalled 40 bags of Neonatal TPN Starter Bag. The product contains 3% Amino Acids (Trophamine) and 10% Dextrose in 250mL IV bags (NDC 72196-0404-1). The affected lot is 36-262157 with expiration date 8/21/2023, and units were distributed nationwide.
The recall was issued because the manufacturer lacks adequate validation data for sanitization cycles. This absence of validation data creates insufficient assurance that the product meets sterility standards—a critical requirement for intravenous medications administered directly to newborns.
Healthcare facilities and providers should identify any remaining units of the affected lot and quarantine them from use. No illnesses or injuries related to this product have been reported to date.
Providers or patients with questions should contact the manufacturer or their healthcare provider for guidance regarding affected units.
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.
- Category
- Drug — Intravenous / Neonatal
- Affected units
- 40
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# 36-262157
- Exp 8/21/2023
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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