FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality

Leaking Containers, Particulate Matter Spark Baxter Recall of IV Solutions

Feb. 3, 2016
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Baxter International is recalling four lots of intravenous IV solutions following complaints of leaking containers and particulate matter.

The recall includes 11 units of a lot of 0.9 percent sodium chloride injection, which is used to reconstitute a powdered drug product. An investigation determined the root cause to be a mechanical issue that affected one machine during a single shift. The company says the problem has been rectified. 

A single unit in a separate lot of the same product also has been recalled after a fragment of cardboard particulate matter was found.  The recalled lots were distributed between Feb. 22 and Dec. 28, 2015.