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Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additi...

FDA Recall #D-465-2015 — Class I — December 17, 2014

Recall #D-465-2015 Date: December 17, 2014 Classification: Class I Status: Terminated

Product Description

Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Reason for Recall

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Recalling Firm

Central Admixture Pharmacy Services, Inc. — Allentown, PA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

3 bags

Distribution

Nationwide

Code Information

lot number 37-74776, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74776-0-3-R, Disp ID: 37-1124585

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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