FDAClass IIJuly 26, 2017

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

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250…

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) 171280006S Exp. 8/6/2017; 171280125S Exp. 8/7/2017; 171290006S Exp. 8/7/2017; 171290028D Exp. 8/8/2017; 171360002S Exp. 8/15/2017; b) 171280011S Exp. 8/7/2017

Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250…
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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