FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality

Leaking Containers, Particulate Matter Spark Baxter Recall of IV Solutions

Feb. 3, 2016

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.