Baxter Issues Recall Due to Particulate Matter
Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.
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
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
