Baxter Recalls IV Solutions

Pharmaceutical Technology Editors

Baxter voluntarily recalls two lots of intravenous solutions due to particulates.

FDA has announced that on Dec. 18, 2016 Baxter International voluntarily recalled two lots of intravenous solutions because of the potential presence of insect particulates. The recall affected lots of 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container, which is intended for IV use as a source of water and electrolytes and may also be used as a priming solution in hemodialysis procedures, and 70% Dextrose Injection (2000 mL) USP, which is indicated as a source of calories and water for hydration. The recalled lots were distributed in the United States between June 6, 2015 and Dec. 16, 2015.

While an FDA press release does not indicate the reasons for the potential presence of the particulates, the particulates were identified as an insect after a customer complaint. The company is advising customers not to use the recalled lots, and replacement lots are available. Adverse reactions may be reported to FDA at www.fda.gov/medwatch/report.htm.

Source: FDA