One lot of 5% Dextrose Injection, USP and four lots of 0.9% Sodium Chloride Injection, USP manufactured by Baxter were recalled due to particulate matter found in the solutions. Injecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs. The root cause of this recall has been identified and resolved.
Dextrose Injection, USP is an intravenously administered injectable indicated as a source of water and calories. Sodium Chloride Injection, USP is an intravenously administered injectable indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. These 50 mL and 100 mL containers are primarily used for admixture of medication and as priming solutions.
Products affected by this recall were packaged in flexible plastic containers with 96 containers per carton. Affected product was distributed to healthcare centers and distributors in the United States and Puerto Rico, Saudi Arabia, Singapore, and the United Arab Emirates. The affected lots were distributed to customers between May 2012 and October 2013.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death