CLASS II Device recall · Reported 9 Nov 2016 · FDA Enforcement Report
Glucose Tolerance Beverage- Orange Concentration recalled
Azer Scientific is recalling Glucose Tolerance Beverage- Orange Concentration, Liquid of Accessory to an In Vitro, distributed nationwide in the US. The recall was initiated on 24 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0329-2017
- FDA event ID
- 75066
- Recalling firm
- Azer Scientific, Morgantown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2016
- FDA classified
- 2 Nov 2016
- Reported
- 9 Nov 2016
- Type
- Voluntary: Firm initiated
- Reason category
- Potency & Assay
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 24 Aug 2016 | Recall initiated by company | |
| 2 Nov 2016 | Classified by FDA | +70 days |
| 9 Nov 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of Specification Microbiological test results
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Out of Specification Microbiological test results
Which lots are affected?
Item Number: 10-O-050 Lot Number: 51426 Expiration Date: 05/2018
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 75066| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Fruit Punch Glucose Concentration, Liquid recalled by Azer Scientific | Azer Scientific | Potency & Assay | Nationwide |
More recalls from Azer Scientific
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Fruit Punch Glucose Concentration, Liquid recalled by Azer Scientific | Azer Scientific | Potency & Assay | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Device Malfunction | CA |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |