The Recall Desk
HighFDA (Drugs)·D-0692-2023·Announced 2023-05-31

Neonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 427 bags of Neonatal TPN Starter Bag due to FDA concerns about sterility assurance. An FDA inspection questioned whether the product met required sterility standards.

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 FDA Class II recall scores High because it involves a risk-of-harm product (neonatal parenteral nutrition for critically ill infants) where no illnesses or injuries have been reported. The recall is based on an FDA inspection that questioned sterility assurance, but no actual contamination or adverse events are confirmed in the source.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 427 bags of Neonatal TPN Starter Bag (Amino Acids Trophamine 3.5%/Dextrose 10% with Calcium and Heparin) in 250 mL single-use bags. The product is used as a parenteral nutrition (intravenous feeding) starter solution for neonates. The recall includes six lot numbers with expiration dates ranging from April 28, 2023 to May 20, 2023.

The recall was initiated because an FDA inspection raised questions about whether these sterile products actually met sterility standards. Lack of adequate sterility assurance in products intended for intravenous use presents a risk when administered to vulnerable neonatal patients.

The product was distributed nationwide throughout the United States. Healthcare providers, hospitals, and clinics that received these recalled lots should stop using them immediately. Affected facilities should check their inventory against the specific lot numbers and expiration dates listed and contact Central Admixture Pharmacy Services, Inc. for return or replacement instructions.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0421-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Parenteral Nutrition
Hazard
  • sterility-defect
  • 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 (12)

  • Lot # 37-893804
  • Exp 04/28/2023
  • 37-894713
  • Exp 04/30/2023
  • 37-896134
  • Exp 05/06/2023
  • 37-896497
  • Exp 05/07/2023
  • 37-897310
  • Exp 05/12/2023
  • 37-899623
  • Exp 05/20/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category