FDAClass IIJuly 26, 2017

Potassium PHOSphate in 0.9% Sodium Chloride Injection recall: Sterility Concern

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in…

Why was Potassium PHOSphate in 0.9% Sodium Chloride Injection recalled?

Lack of Assurance of Sterility; media fill failure at manufacturer

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?

Lots: a) 171180027S Exp. 7/29/2017, 171220058D Exp. 8/1/2017, 171230013S Exp. 8/2/2017, 171360008S Exp. 8/14/2017, 171360019D Exp. 8/15/2017, 171380085D Exp. 8/17/2017, 171430069D Exp. 8/22/2017, 171560025D Exp. 9/4/2017; b) 171240007S Exp. 8/3/2017, 171280055D Exp. 8/7/2017, 171320003D Exp. 8/10/2017, 171320008S Exp. 8/13/2017, 171360005S Exp. 8/14/2017, 171370011S Exp. 8/16/2017, 171380086D Exp. 8/17/2017, 171500071D Exp. 8/29/2017

Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in…
Recalling firm
PharMedium Services, Llc
Quantity
N/A
Distribution
Nationwide
Recall date
July 26, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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