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Azer Scientific, Inc. recalls Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro
Recalled November 9, 2016 · FDA recall Z-0329-2017 · Azer Scientific
Hazard
Out of Specification Microbiological test results · FDA Class II
Units
426 cases
Sold at
Nationwide Distribution
Description
Out of Specification Microbiological test results
Product
Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.
Manufacturer(s)
Azer Scientific, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →