The Recall Desk
HighFDA (Drugs)·D-1115-2023·Announced 2023-09-06

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.

What this means for you

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
Hazard
  • sterility-risk
  • contamination-risk

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.

Related recalls

Same category