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Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV B...

FDA Recall #D-1000-2023 — Class II — July 14, 2023

Recall #D-1000-2023 Date: July 14, 2023 Classification: Class II Status: Terminated

Product Description

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1

Reason for Recall

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Recalling Firm

Central Admixture Pharmacy Services, Inc. — Phoenix, AZ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

516 bags

Distribution

Nationwide in the USA

Code Information

Lot: 36-251200, 36-251209, Exp. 7/10/2023; 36-252140, Exp. 7/16/2023; 36-256334, 36-256335, Exp. 7/29/2023.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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