Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: sterility-failure
contamination
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 →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

See all →

Moderate
Pediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
Severe
Pediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
Severe
Injectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
High
Ephedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
High
Fentanyl injectable syringes recalled nationwide for sterility assurance failure
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Same hazard · sterility failure