The Recall Desk
HighFDA (Drugs)·D-0687-2023·Announced 2023-05-31

Neonatal Parenteral Nutrition Starter Bags Recalled for Sterility Concerns

Central Admixture Pharmacy Services is recalling 258 bags of Neonatal TPN Starter Bag due to lack of assurance of sterility following an FDA inspection. The product is distributed nationwide.

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: FDA Class II recall of a parenteral nutrition product for neonates with sterility assurance concerns; no illnesses or injuries have been reported. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported, as sterility failure in a parenteral product could result in serious infection in vulnerable newborns.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Neonatal TPN Starter Bag (Trophamine 3% / Dextrose 5% with Calcium), 250 mL bags intended for newborn intravenous nutrition. A total of 258 bags are affected across lot numbers 37-894313, 37-895257, 37-897360, 37-897890, and 37-900964, with expiration dates ranging from April to May 2023.

The FDA inspection called into question whether these products maintain proper sterility assurance as intended. Sterility is critical for parenteral nutrition products administered directly into the bloodstream of vulnerable newborn patients.

The product was distributed nationwide. Healthcare facilities that received affected lot numbers should discontinue use immediately. Patients who received this product should be monitored per standard clinical protocols, and healthcare providers should contact the manufacturer for replacement product and further guidance.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0413-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Parenteral Nutrition
Hazard
  • sterility-assurance-failure
  • infection-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 (10)

  • Lot # 37-894313
  • Exp 04/29/2023
  • 37-895257
  • Exp 05/04/2023
  • 37-897360
  • Exp 05/12/2023
  • 37-897890
  • Exp 05/13/2023
  • 37-900964
  • Exp 05/26/2023

Distribution

Distributed nationwide across the United States.

Related recalls

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