FDAFDA · Food and drugs·Recall number Z-0329-2017
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.
Published November 9, 2016 · Recall initiated: August 24, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out of Specification Microbiological test results
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Azer Scientific, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Item Number: 10-O-050 Lot Number: 51426 Expiration Date: 05/2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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