Recalls

Injectable solutions recalled due to particle contamination

syringe Injectable solutions recalled due to particle contamination Injectable solutions used to hydrate or add electrolytes to some patients are being recalled because there are particles floating in the products that if injected into patients could cause serious and even deadly health consequences.

The recall involves one lot of 5% dextrose injection and four lots of 0.9% sodium chloride injection, both manufactured by Baxter International. If injected, a product containing particulate matter may block blood vessels which could cause strokes, heart attacks or organ damage such as to the kidneys or liver. There is also the possibility of allergic reactions, local irritations, and inflammation in tissues and organs.

Dextrose injections are intravenously administered solutions of water and calories. Sodium chloride injections are intravenously administered solutions of water and electrolytes used 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.

The recalled products were packaged in flexible plastic containers with 96 containers per unit. Affected containers were distributed to health care centers and distributors in Saudi Arabia, Singapore, United Arab Emirates, and the United States and Puerto Rico between May 2012 and October 2013.

Customers were notified of the recall and instructed not to use the affected products and to arrange for return. Any side effects from these products should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA