FDAClass IIJuly 8, 2015

TPN 3:1 recall: Sterility Concern

TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, K Phos…

Why was TPN 3:1 recalled?

Lack of Assurance of Sterility: Sterility of product is not assured.

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?

All product compounded between May 14, 2015 and May 27, 2015

Product
TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, K Phos…
Recalling firm
Lincare, Inc.
Quantity
5 Bags
Distribution
United States including: Arkansas
Recall date
July 8, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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