FDA Drug recall D-0683-2023

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pha…

FDA Drug
Class II
terminated
Published 2023-05-31

On 2023-05-31 the FDA classified a Class II recall of Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pha… by Central Admixture Pharmacy Services, citing lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0683-2023
Classification	Class II
Status	terminated
Initiated	2023-04-28
Published	2023-05-31
Last updated	2026-09-13 11:52 UTC
Company	Central Admixture Pharmacy Services
Distribution	US

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.

Reason

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Identifiers

code_info	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; 37-89… 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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0683-2023%22

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