Baxter Recalls IV Solutions

January 27, 2016
Pharmaceutical Technology Editors

Baxter has voluntarily recalled lots of IV solutions due to potential container leakages and particulate matter.

On Jan. 26, 2016, Baxter International announced a voluntary recall, as a result of customer complaints, of four lots of intravenous (IV) solutions due to the potential for leaking containers and particulate matter. The incidents were discovered before the products were administered to patients, and Baxter has not received any reports of adverse events as of January 26.

Baxter confirmed leaking containers in 11 units of one lot of 0.9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container. Baxter investigated the leaks and found the root cause to be a mechanical issue, which the company has remedied.  A separate lot of 0.9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container contained a fragment of cardboard. The recalled lots were distributed nationwide between Feb. 22, 2015 and Dec. 28, 2015.  

Additional particulates were found in a unit from a lot of Metronidazole Injection, USP 500mg/100mL that were identified as cloth fiber particulate matter. The lot being recalled was distributed to customers and distributors nationwide between Oct. 9, 2015 and Jan. 18, 2016. A unit from a lot of Clinimix E 5/15 (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) was found to contain a small fragment of dried skin particulate matter. The lot being recalled was distributed to customers and distributors nationwide between May 29, 2015 and Dec. 3, 2015.

More information on the recalled products can be found on FDA’s website.

Source: FDA