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Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, pa...

FDA Recall #D-0692-2023 — Class II — April 28, 2023

Recall #D-0692-2023 Date: April 28, 2023 Classification: Class II Status: Terminated

Product Description

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0421-1.

Reason for Recall

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

Recalling Firm

Central Admixture Pharmacy Services, Inc. — Allentown, PA

Classification

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

Product Type

Drugs

Product Quantity

427 bags

Distribution

Nationwide in the USA.

Code Information

Lot # 37-893804, Exp 04/28/2023; 37-894713, Exp 04/30/2023; 37-896134, Exp 05/06/2023; 37-896497, Exp 05/07/2023; 37-897310, Exp 05/12/2023; 37-899623, Exp 05/20/2023

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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