Search results for "FDA update"


 
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Extended-release metformin recalled due to impurity

Companies recently recalled metformin hydrochloride for extended-release oral suspension and metformin hydrochloride extended-release tablets USP due to excess amounts of N-nitrosodimethylamine.
https://diabetes.acponline.org/archives/2020/10/09/10.htm
9 Oct 2020

Hemoglobin A1c test approved for diagnosis

The FDA recently approved the first hemoglobin A1c (HbA1c) test specifically labeled for diagnosing diabetes.
https://diabetes.acponline.org/archives/2013/08/09/8.htm
9 Aug 2013

Glucose meter recalled due to incorrect unit of measure

The TRUE METRIX AIR Blood Glucose Meter displayed glucose results in mmol/L rather than mg/dL.
https://diabetes.acponline.org/archives/2020/05/08/7.htm
8 May 2020

Cybersecurity warning issued for certain insulin pumps

The risks are related to the pumps' wireless communication with other devices, such as blood glucose meters and continuous glucose monitoring systems.
https://diabetes.acponline.org/archives/2019/07/12/6.htm
12 Jul 2019

Metformin testing finds negligible levels of nitrosamine impurity

Levels of N-nitrosodimethylamine found in metformin products ranged from not detectable to low, and there are no U.S. recalls at this time.
https://diabetes.acponline.org/archives/2020/02/14/8.htm
14 Feb 2020

Glucagon recalled due to detaching needles

Six batches of GlucaGen HypoKit (glucagon [rDNA origin] for injection) were recalled due to the possibility of needle detachment, the FDA recently announced.
https://diabetes.acponline.org/archives/2016/09/16/8.htm
16 Sep 2016

Insulin pumps recalled due to incorrect dosing

The manufacturer of the pumps, which deliver insulin to patients with type 1 diabetes, has received a total of 26,421 complaints and is aware of 2,175 injuries and one death.
https://diabetes.acponline.org/archives/2020/03/13/8.htm
13 Mar 2020

FDA issues draft guidance on blood glucose monitors

The updated recommendations apply to industry and, when finalized, will update previous guidance issued in 2016.
https://diabetes.acponline.org/archives/2018/12/14/6.htm
14 Dec 2018

Metformin may contain nitrosamine impurity

The FDA is investigating whether metformin in the U.S. market contains N-nitrosodimethylamine. Low levels of the impurity have been found in the drug in other countries; however, there are no U.S. recalls at this time.
https://diabetes.acponline.org/archives/2019/12/13/9.htm
13 Dec 2019

Diabetes device recalled due to risk of fire

The FDA recently announced a class I recall of the Omnipod DASH Insulin Management System Personal Diabetes Manager due to reports of battery issues, including battery swelling, fluid leakage, and extreme overheating that may pose a fire hazard.
https://diabetes.acponline.org/archives/2022/12/09/10.htm
9 Dec 2022

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