The Recall Desk
HighFDA (Drugs)·D-0685-2023·Announced 2023-05-31

Neonatal TPN Starter Bags Recalled for Sterility Assurance Issue

Central Admixture Pharmacy Services recalls 138 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned the products' sterility assurance. Affected lots expire between April and May 2023.

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 is a Class II FDA recall with no reported illnesses or injuries in the source. The hazard—lack of sterility assurance on a high-risk parenteral nutrition product for neonates—represents a theoretical risk of contamination. Per the rubric, theoretical hazards without reported injury score at most 3.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 138 bags of Neonatal TPN Starter Bag (Amino Acids [Trophamine] 3.5%/Dextrose 10% with Calcium), packaged in 250 mL per bag. This prescription-only product is distributed nationwide.

The recall was initiated after an FDA inspection called into question the sterility assurance of the products. The affected lots are: Lot # 37-894709 (expiration 04/30/2023), Lot # 37-896128 (expiration 05/06/2023), and Lot # 37-897894 (expiration 05/13/2023).

Patients and healthcare providers who have this product should contact Central Admixture Pharmacy Services, Inc. for guidance on the product status and next steps.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0407-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Parenteral Nutrition
Hazard
Affected units
138

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 (6)

  • Lot # 37-894709
  • Exp 04/30/2023
  • 37-896128
  • Exp 05/06/2023
  • 37-897894
  • Exp 05/13/2023

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 →

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