The Recall Desk
HighFDA (Drugs)·D-0690-2023·Announced 2023-05-31

Neonatal TPN Starter Bags Recalled Over Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 418 bags of neonatal TPN starter bags nationwide due to loss of sterility assurance following FDA inspection. The prescription product contains amino acids, dextrose, calcium, and heparin.

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 involves a critical sterile injectable product for vulnerable neonates. While no illnesses or injuries are reported in the source, the loss of sterility assurance in a parenteral nutrition product poses significant theoretical risk of infection. Per the rubric, this fits the High category as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Neonatal TPN Starter Bag (Amino Acids [Trophamine] 3%/Dextrose 5% with CALCIUM and HEPARIN), a sterile injectable nutrition product packaged in 250 mL bags. The product has NDC 71285-0419-1 and was distributed nationwide in the United States.

The recall was initiated after an FDA inspection raised questions about the sterility of the products. The firm could not provide assurance that the products maintained their required sterility. A total of 418 bags are affected across five lot numbers, with expiration dates ranging from April 28, 2023 to May 19, 2023.

This is a prescription-only product used to provide critical amino acids and nutrients to newborns. Healthcare providers who dispensed affected lots should identify any units that may have been used and monitor patients for signs of infection. Patients should discontinue use of affected lots and consult their healthcare provider for alternative products.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% 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 71285-0419-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Parenteral Nutrition / Sterile Injectable
Hazard
  • sterile-contamination

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 # 37-893810
  • Exp 04/28/2023
  • 37-894698
  • Exp 04/30/2023
  • 37-896144
  • Exp 05/06/2023
  • 37-897896
  • Exp 05/13/2023
  • 37-899172
  • Exp 05/19/2023

Distribution

Distributed nationwide across the United States.

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