No doubt when Jose Almedia took over as CEO of Baxter International in the first week of 2016, he was hoping the new year would bring a clean slate. It hasn’t turned out that way. As he took the helm, the company was issuing another recall involving its intravenous (IV) solutions. The latest recall involves two lots of solutions used to replenish electrolytes and increase caloric supply in patients after a confirmed customer complaint that a bug was floating in bags of the solution.
Baxter suffered through 2015 with repeated product recalls and quality control issues plaguing its IV solutions and other products, with problems ranging from leaking containers to contamination with mold or other particulate that could result in serious patient injury or death. Lowlights of the recalls include:
- Fifteen lots of IV solutions due to presence of particulate in the solutions that could lead to inflammatory reactions and other adverse events.
- Four product codes of Vascu-Gard peripheral vascular patches, because customers could not discern the smooth side of the patch from the rough side. A mix-up in patch placement could lead to thrombosis and embolism.
- 140,000 bags of sodium chloride due to the presence of mold, which if injected into patients could cause serious adverse events.
- One lot of IV solutions because the containers were leaking, particulate was seen in the solutions, and port protectors were missing.
The latest recall involves 0.9% Sodium Chloride Injection used as a source of water and electrolytes or a priming solution for hemodialysis procedures, and Dextrose Injection, a source of calories and water for hydration. Both are commonly used in patients in health care settings. Injecting solutions containing such particulate matter could block blood vessels, resulting in stroke, heart attack or damage to vital organs, as well as cause allergic reactions, local irritation and inflammation in tissue and organs.
In the past two years, the company has also been hit with FDA warning letters over questionable manufacturing practices at its plant in Jayuya, Puerto Rico. Baxter has paid millions in recent years to correct problems and settle lawsuits related to tainted products.
Sources: Fierce Pharma, Chicago Tribune