The Recall Desk
HighFDA (Drugs)·D-0686-2023·Announced 2023-05-31

Neonatal TPN Starter Bags Recalled for Sterility Assurance Issues

Central Admixture Pharmacy Services is recalling 167 bags of neonatal TPN Starter Bag due to FDA concerns about product sterility identified during inspection.

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 (sterile pharmaceutical for neonates) where the hazard—lack of sterility assurance—has not resulted in reported illnesses. Per the severity rubric, this qualifies as High (score 3).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 167 bags of Neonatal TPN Starter Bag, containing Amino Acids (Trophamine) 4% and Dextrose 10% in 250 mL bags. The recall was initiated after an FDA inspection raised questions about the sterility of these products, which are intended to be sterile pharmaceuticals.

The affected lot numbers are 37-896130 (Exp 05/06/2023), 37-897957 (Exp 05/13/2023), 37-899605 (Exp 05/20/2023), and 37-901357 (Exp 05/27/2023). These products were distributed nationwide in the USA.

Neonatal TPN (Total Parenteral Nutrition) products are used to provide essential nutrients to newborns, particularly those unable to feed normally. A lack of sterility assurance in these products poses a risk of bacterial contamination and infection in vulnerable neonatal patients.

Healthcare providers and patients who have received this product should contact their healthcare provider if they have concerns. Consult the recall notice from the FDA or contact the manufacturer for guidance on product disposition and alternatives.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0408-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Parenteral Nutrition
Hazard
  • sterility-assurance
  • 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 (8)

  • Lot # 37-896130
  • Exp 05/06/2023
  • 37-897957
  • Exp 05/13/2023
  • 37-899605
  • Exp 05/20/2023
  • 37-901357
  • Exp 05/27/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category