FDAClass IISeptember 2, 2015

0.9% Sodium Chloride Injection recall

0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

Why was 0.9% Sodium Chloride Injection recalled?

Procedures for the acceptance and control of in-process product have not been adequately established.

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?

KH04143,exp. 07/2016; KH04145, exp. 08/2016; KH04153, exp. 11/2016; KH04155, exp. 12/2016

Product
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Recalling firm
MRP, LLC dba AMUSA
Quantity
551 cases
Distribution
Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.
Recall date
September 2, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls