Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate Recalled due to Risk of Metabolic Alkalosis

FDA issued a Class 1 recall of Naturalyte and Granuflo Acid Concentrate because inappropriate prescription of these products can contribute to metabolic alkalosis leading to serious adverse events, including death.

Background of Naturalyte and Granuflo Acid Concentrate

The Naturalyte and Granuflo Dry Acid Concentrate, by Fresenius Medical Care North America, are used during hemodialysis for the treatment of acute and chronic renal failure. The concentrate is used with a three-stream hemodialysis machine specifically calibrated for acid and bicarbonate concentrates.

Hemodialysis

FDA Alert on Naturalyte and Granuflo Acid Concentrate

Due to the concentration of acetate or sodium diacetate in Naturalyte and Granuflo Acid Concentrate, inappropriate prescription can lead to increased bicarbonate levels contributing to metabolic alkalosis posing a significant risk factor associated with cardiac arrhythmia, hypercapnia, hypoxemia, hypokalemia, low blood pressure and cardiopulmonary arrest.

The affected serial numbers from the recall are:

Naturalyte Liquid Acid Concentrate from:

08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8, 08-3201-4, 08-3231-1, 08-3251-9, 08-3301-2, 08-4123-1, 08-4223-7, 08-4225-1, 08-4230- 2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1, 13-3251-9, 13-4123-1, 13-4220-1, 13-4225-1, 13-4325-1

Naturalyte GranuFlo (powder) Acid Concentrate from:

OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B

This product was manufactured and distributed from January 2008 to June 2012.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

FDA Recommendation on Naturalyte and Granuflo Acid Concentrate

“Health care providers should review the dialysate acid concentrate labeling for the specific concentrate that they prescribe to determine the components that can contribute to the patient’s overall bicarbonate levels. The levels of acetate, citrate and/or acetic acid vary by formulation and by manufacturer. Be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.”

Contacting the FDA to report cases with Naturalyte and Granuflo Acid Concentrate

In case of detection of adverse events or side effects related to the use of Naturalyte and Granuflo Acid Concentrate, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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