FDAClass IApril 15, 2015

Olathe Medical Center recall: Sterility Concern

Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, 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.

Why was Olathe Medical Center recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

lot number 37-74547, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74547-0-1-R, Disp ID: 37-1124708

Product
Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, 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.
Recalling firm
Central Admixture Pharmacy Services, Inc.
Quantity
1 bag
Distribution
Nationwide
Recall date
April 15, 2015
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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