The Recall Desk
HighFDA (Drugs)·D-0696-2023·Announced 2023-05-31

Neonatal TPN Bags Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 259 neonatal TPN bags nationwide due to lack of assurance of sterility following FDA 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 FDA Class II recall of a sterile injectable product where sterility assurance cannot be verified qualifies as 'High' per the rubric: it is a risk-of-harm product without reported injury, and it lacks the hospitalization reports needed for 'Severe.'

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 259 units of Neonatal TPN Starter Bag (Amino Acids 3% / Dextrose 5% with low calcium and HEPARIN, 250 mL per bag) due to lack of assurance of sterility. An FDA inspection raised questions about whether these sterile injectable pharmaceutical products maintained required sterility standards.

The affected product was distributed nationwide in the United States. The recall involves five lot numbers with expiration dates ranging from April 29, 2023 to May 21, 2023 (Lot #37-894338, 37-896505, 37-898301, 37-898305, 37-900061).

Neonatal TPN (total parenteral nutrition) is a compounded injectable nutrition product for newborns. Because these are sterile injectable products, any uncertainty about sterility assurance poses a significant health concern.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with low 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 71285-0427-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable / Parenteral Nutrition
Hazard
Affected units
259

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 (9)

  • Lot # 37-894338
  • Exp 04/29/2023
  • 37-896505
  • Exp 05/07/2023
  • 37-898301
  • Exp 05/14/2023
  • 37-898305
  • 37-900061
  • Exp 05/21/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 108 products in this recall →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · sterility failure

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