The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0683-2023·Announced 2023-05-31

Neonatal TPN Starter Bag Recalled for Sterility Assurance Issues

Central Admixture Pharmacy Services recalls 558 bags of Neonatal TPN Starter Bag nationwide due to lack of sterility assurance identified during 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: FDA Class II recall of a parenteral nutrition product with lack of sterility assurance following an FDA inspection. No reported illnesses or hospitalizations are mentioned. This meets the rubric criterion for Score 3: 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 10% with calcium, NDC 71285-0405-1) in 250 mL bags distributed nationwide. The recall affects 558 bags.

The recall was initiated due to lack of assurance of sterility. An FDA inspection called into question the sterility of these products, which are intended to be sterile for intravenous use in neonates.

Affected lot numbers and expiration dates are: Lot 37-893806 (Exp 04/28/2023), 37-894701 (Exp 04/30/2023), 37-895626 (Exp 05/05/2023), 37-897277 (Exp 05/12/2023), 37-899175 (Exp 05/19/2023), and 37-900971 (Exp 05/26/2023). Healthcare facilities and pharmacies should immediately stop distribution and quarantine affected bags.

Patients who may have received this product should contact their healthcare provider.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/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 71285-0405-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug
Hazard
Affected units
558

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 (12)

  • Lot # 37-893806
  • Exp 04/28/2023
  • 37-894701
  • Exp 04/30/2023
  • 37-895626
  • Exp 05/05/2023
  • 37-897277
  • Exp 05/12/2023
  • 37-899175
  • Exp 05/19/2023
  • 37-900971
  • Exp 05/26/2023

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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