The Recall Desk
HighFDA (Drugs)·D-1120-2023·Announced 2023-09-06

Neonatal Injectable Nutrition Bags Recalled for Lack of Sterility Validation

Central Admixture Pharmacy Services is recalling 132 bags of neonatal injectable nutrition due to unvalidated sterilization processes. The lack of sterility assurance creates potential infection risk for neonatal patients receiving these products.

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 a risk-of-harm product (injectable nutritional solution for neonates) where sterility cannot be assured due to unvalidated manufacturing processes. No illnesses or injuries have been reported. The absence of reported harm and the theoretical nature of the hazard support a High severity rating per the established rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 132 bags of Neonatal TPN (Total Parenteral Nutrition) Starter Bags containing Amino Acids (trophamine) 3.5% / Dextrose 10% with low calcium and heparin. The recalled product is supplied in 250mL IV bags for intravenous administration to neonatal patients.

The recall was issued due to lack of validation data for the manufacturer's sterilization cycles. Without adequate validation, the manufacturer cannot assure that the product maintains sterility. Non-sterile intravenous products carry significant risk of microbial contamination and serious infection in susceptible neonatal patients.

The affected lots are: Lot# 36-260018 (expiration 8/19/2023) and Lot# 36-262155 (expiration 8/21/2023). These products were distributed nationwide in the USA. Healthcare facilities should identify and quarantine any remaining stock of these lot numbers.

Healthcare providers should cease use of affected bags immediately and contact Central Admixture Pharmacy Services, Inc. (located at 2200 South 43rd Avenue, Phoenix, AZ 85043) or the FDA for guidance on replacement products. No illnesses have been reported in connection with this recall.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Parenteral Nutrition / Injectable
Hazard
  • lack-of-sterility
  • 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 (4)

  • Lot# 36-260018
  • Exp 8/19/2023
  • 36-262155
  • Exp 8/21/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category