FDAClass IISeptember 6, 2023

Neonatal TPN Starter Bag recall: Sterility Concern

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only…

Why was Neonatal TPN Starter Bag recalled?

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 36-260018, Exp 8/19/2023, 36-262155, Exp 8/21/2023 ;

Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only…
Recalling firm
Central Admixture Pharmacy Services, Inc.
Quantity
132 bags
Distribution
Nationwide in the USA
Recall date
September 6, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls