Baxter Issues Recall Due to Particulate Matter

Jul 11, 2014
By BioPharm International Editors

Baxter Healthcare Corp. has initiated a nationwide recall of more than 20,000 containers of Brevibloc Premixed Injection, esmolol hydrochloride in sodium chloride due to the presence of particulate matter.

According to FDA’s July 9 enforcement report, Baxter received complaints of discolored solution identified as subvisible particles of iron oxide that are agglomerating. Baxter issued the recall voluntarily on June 16, 2014.

The recall involved 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton.

Source: FDA