Z-0329-2017Class II

Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an...

Name: Z-0329-2017 Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an...
Creator: Azer Scientific, Inc.
Published: 2016-08-24
License: https://open.fda.gov/license/

Azer Scientific, Inc. / initiated 2016-08-24 / Terminated

FDA source

Azer Scientific, Inc. began a recall of 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... on 2016-08-24. FDA classified it as Class II and gives the reason as "Out of Specification Microbiological test results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0329-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-24
Posted: 2016-11-02
Terminated: 2017-10-06
Recalling firm: Azer Scientific, Inc.
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.
Product code: MRV Drink, Glucose Tolerance
Reason for recall: Out of Specification Microbiological test results
FDA root cause: Unknown/Undetermined by firm
Action: Azer Scientific mailed an Urgent Medical Device Recall letter dated August 30, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to discontinue use of product and discard to avoid further distribution or use and to notify their customers/end users of the recall. Customers were asked to acknowledge receipt of the letter by completing the attached form and faxing it to (610) 901-3046. Customers with questions were instructed to call (610) 524-5810.
Quantity in commerce: 426 cases
Distribution: Nationwide Distribution
Product codes and lots: Item Number: 10-O-050 Lot Number: 51426 Expiration Date: 05/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0329-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0329-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0330-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02

Product code MRV

K042183Class IIGlucose Tolerance BeverageEver Scientific / cleared 2004-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)