Agency classClass IIOur severity:High FDA (Drugs)·D-0691-2023·Announced 2023-05-31

Neonatal Injectable TPN Bags Recalled Over Sterility Assurance Concerns

Central Admixture Pharmacy Services recalled 877 bags of neonatal TPN starter bags nationwide due to lack of sterility assurance following an 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 is a Class II recall of a high-risk parenteral product with sterility assurance failure. As a risk-of-harm product with no currently reported illnesses, the rubric score is 3.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 877 bags of Neonatal TPN Starter Bag (Trophamine 3% / Dextrose 10% with Calcium and Heparin) distributed nationwide. The recall was initiated after an FDA inspection raised concerns about whether the manufacturer could assure the product's sterility.

The affected product is a 250 mL injectable formulation intended for neonatal patients. Specific lot numbers and expiration dates have been identified. Because this product is intended to be sterile, any compromise in sterility assurance represents a potential risk of infection, particularly for vulnerable neonatal patients.

The recalled product

Product: Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/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 71285-0420-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Parenteral / Injectable
Hazard: lack-of-sterility
infection-risk
Affected units: 877

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 (18)

Lot # 37-894314
Exp 04/29/2023
37-894690
37-894699
Exp 04/30/2023
37-895627
Exp 05/05/2023
37-896494
Exp 05/07/2023
37-897082
Exp 05/11/2023
37-897955
Exp 05/13/2023
37-899254
Exp 05/19/2023
37-900057
37-900060
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 →

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Pediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
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FDA (Drugs) · 2026-07-01
Severe
Injectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
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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 · lack of sterility