Search results for "FDA update"
Extended-release metformin recalled due to nitrosamine impurities
A company recently expanded a recall of metformin hydrochloride extended-release tablets USP due to excess amounts of N-nitrosodimethylamine.
https://diabetes.acponline.org/archives/2021/01/08/7.htm
8 Jan 2021
Semaglutide injection approved for chronic weight management
First approved to treat type 2 diabetes in 2017, the drug has a new indication for chronic weight management in adults with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related condition, such as type 2 diabetes, and those with a BMI of 30 kg/m2 or greater.
https://diabetes.acponline.org/archives/2021/06/11/11.htm
11 Jun 2021
Nearly 1.5 million insulin syringes recalled
Recalled syringes may have graduated markings that are printed incorrectly on the syringe barrel.
https://diabetes.acponline.org/archives/2021/07/09/8.htm
9 Jul 2021
Metformin recalled due to nitrosamine impurity
The recall includes two lots of metformin hydrochloride extended-release tablets USP (750 mg) manufactured in India and distributed in the U.S.
https://diabetes.acponline.org/archives/2021/07/09/9.htm
9 Jul 2021
Glucagon emergency kits recalled due to loss of potency
A product complaint reported that the vial of glucagon in the kit was in liquid form instead of powder form. This could cause it to fail to treat severe hypoglycemia due to loss of potency, the FDA said.
https://diabetes.acponline.org/archives/2021/10/08/8.htm
8 Oct 2021
More metformin recalled due to nitrosamine impurity
The recall includes 33 lots of metformin hydrochloride extended-release tablets USP (750 mg) manufactured in India and distributed in the U.S.
https://diabetes.acponline.org/archives/2022/01/14/6.htm
14 Jan 2022
Insulin recalled due to potential missing label
Mylan Pharmaceuticals Inc. is recalling one batch of insulin glargine injection due to the potential for a missing label on some pens within a labeled carton.
https://diabetes.acponline.org/archives/2022/02/11/6.htm
11 Feb 2022
FDA approves new heart failure indication for SGLT-2 inhibitor
Originally approved in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes, the sodium-glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance) is now approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.
https://diabetes.acponline.org/archives/2022/03/11/10.htm
11 Mar 2022
Alert warns about cybersecurity risk with insulin pump system
A potential issue with the Medtronic MiniMed 600 Series Insulin Pump System's communication protocol could allow unauthorized access to the device, the FDA said.
https://diabetes.acponline.org/archives/2022/10/14/9.htm
14 Oct 2022
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