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Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV B...

FDA Recall #D-1122-2023 — Class II — August 17, 2023

Recall #D-1122-2023 Date: August 17, 2023 Classification: Class II Status: Terminated

Product Description

Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1

Reason for Recall

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

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

108 bags

Distribution

Nationwide in the USA

Code Information

Lot# 36-260017, Exp 8/19/2023 ;

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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