Fresenius Kabi USA Recalls Magnesium Sulfate Due to Possible Glass Particles
Fresenius Kabi USA, LLC, is voluntarily recalling one lot of magnesium sulfate injection, USP because of possible glass particles in the vials, according to an FDA alert. The product, with lot number 6103882, is labeled with Product Code 6450 and is packaged as 500 mg/mL strength in 50 mL glass vials in trays of 25. The lot was shipped in the US between May 30, 2012, and June 6, 2012, and has an expiration date of October 31, 2014. FDA recommends that any unused product be returned to the supplier and asks that health care providers and patients report any reactions related to the company’s products to the FDA MedWatch Safety Information and Adverse Event Reporting Program. Reports to FDA MedWatch can be made using the online form or by following the instructions on the Web site to submit a report by mail or fax.