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Prescription errors on Naturalyte and Granuflo Acid Concentrate cause for Class I recall

Filed June 29th, 2012 Laurie

The Food and Drug Administration has issued a Class I recall on Naturalyte and Granuflo Acid Concentrate due to errors in the concentrations of certain agents included in it. Improper prescriptions delivered to patients undergoing hemodialysis may suffer serious injuries or death as a result.

The FDA issues Class I recalls when it determines use of a product could result in serious injuries or death. The product included in this recall is manufactured by Fresenius Medical Care North America.

Fresenius is “cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate)” included in the product included in the recall action. If these levels are not correct, a person undergoing hemodialysis can suffer a metabolic alkalosis, brought on by increased level of serum bicarbonate. Metabolic alkalosis can cause low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. If these symptoms go untreated, they could result in cardiopulmonary arrest.

Naturalyte and Granuflo Acid Concentrate distributed from January 2008 through January 2012 is included in the FDA action. The following Serial numbers of each product are included:

Serial numbers for Naturalyte Liquid Acid Concentrate range 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

Serial numbers for Naturalyte GranuFlo (powder) Acid Concentrate range 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

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