One lot of generic Epsom salt, also known as magnesium sulfate, made and distributed by Fresenius Kabi has been recalled because it may be contaminated with glass particles.
The Fresenius magnesium sulfate recall was announced on May 27, following an inspection of a product sample that revealed the glass particle contamination. The company said the recall was a precautionary measure.
The recalled Epson salt is in injection form and used for electrolyte therapy to treat magnesium deficiency, and to prevent seizures during pregnancy. The recall affects one lot of Magnesium Sulfate Injection, USP with a lot number of 6103882. The recalled vials have Product Code 6450 and are packaged as 500 mg/mL strength in 50 m? glass vials, with 25 vials per tray. It was shipped between May 30, 2012, and June 5, 2012, and has an expiration date of October 31, 2014.
If injected, the particles could cause damage to blood vessels in the lungs, swelling and granuloma formation. However, there have been no injuries or illnesses reported in connection with this recall. Doctors or patients who experience adverse events after using the recalled magnesium sulfate injections should contact Fresenius Kabi’s Vigilance and Medical Affairs office at (800) 551-7176.
Fresenius Kabi is one of four companies that make up Fresenius SE & Co. KGaA. One of its sister units, Fresenius Medical Care, is currently under fire for how it handled the recall of NaturaLyte and GranuFlo, two dialysis products that were commonly used in Fresenius dialysis clinics and clinics owned by other companies.
Several hundred Fresenius dialysis treatment lawsuits have been filed in courts throughout the United States on behalf of individuals who suffered sudden heart problems and wrongful death lawsuits for families of individuals who died during or shortly after treatment. The complaints allege that Fresenius withheld important information from doctors at their own clinics and from the entire medical community about the risks associated with Granuflo and NaturaLyte, including the importance of monitoring bicarbonate levels for patients treated with the products.
Fresenius issued an internal memo to their own clinics in November 2011, indicating that an internal review of patients treated at 667 Fresenius dialysis clinics in 2010 and found at least 941 instances where individuals suffered cardiac arrest during dialysis treatment. The memo warned physicians at Fresenius clinics about the importance of monitoring bicarbonate levels, but the company failed to provide this information to other clinics that used Granuflo and NaturaLyte.
After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers, which the FDA has classified as a NaturaLyte and Granuflo recall.