The Recall Desk

FDA (Devices) recall action 75066

Azer Scientific, Inc. recalled 2 products on 2016-11-09

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-11-09
Critical
0
Units
1,567

Why these products were recalled

Out of Specification Microbiological test results

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2016-11-09

    Azer Scientific Recalls Fruit Punch Glucose Due to Microbiological Test Failures

    Azer Scientific is recalling Fruit Punch Glucose, 100 Gram Concentration, due to out-of-specification microbiological test results.

    Product
    Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-11-09

    Azer Scientific Recalls Glucose Tolerance Beverage Due to Microbiological Test Failures

    Azer Scientific, Inc. is recalling 426 cases of Orange Glucose Tolerance Beverage due to 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…
    Category
    Distribution
    0 states