FDAClass IApril 15, 2015

University of Alabama Birmingham TPN Neonatal Starter recall: Sterility Concern

University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, 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 University of Alabama Birmingham TPN Neonatal Starter 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 37-74529, EXP: 24 DEC 2014, Made on 15 DEC 2014, CAPS Rx: 37-74529-0-20-R, Disp ID: 37-1124540

Product
University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, 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
20 bags
Distribution
Nationwide
Recall date
April 15, 2015
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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