Drug recall: Insulin Glargine recalled due to this reason

The product information, batch number and expiry date information are present on the carton.

316
Drug recall
Drug recall

Last Updated on October 10, 2024 by The Health Master

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine- yfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton.

This product is not the branded Semglee vial but the unbranded Insulin Glargine- yfgn vial. This batch is being recalled due to the potential for the label to be missing on some vials.

The product information, batch number and expiry date information are present on the carton.

This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between December 9, 2021, and March 4, 2022. The recalled batch is as follows:

NDC #Name and StrengthSizeBatch#Expiry
49502-393-80Insulin Glargine (Insulin glargine-yfgn)
Injection, 100 units/mL (U-100)
10 mL vialBF21002800Aug 2023

Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

This recall does not pertain to the branded interchangeable biosimilar, Semglee® (insulin glargine-yfgn) injection but to the unbranded interchangeable biosimilar Insulin Glargine-yfgn vial.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

The company has initiated the recall of batch BF21002800 and notified its distributors and retailers by letter and is arranging for return of all recalled products.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Moderna recalls thousands of C-19 vaccine doses

Drug recall: Certain Products recalled due to Microbial Contamination

Drug Recall: IDArubicin Hydrochloride Injection recalled due to this reason

Drug recall: Orphenadrine Citrate 100 mg Extended Release Tablets recalled due to this reason

Drug recall: This drug recalled due to detection of NDMA

Drug recall: Some lots of Blood Pressure Drug due to this reason

4 Medical Devices Parks to come up in a total of 1,326 acres

CDSCO Committee gives approval to Sun Pharma for Ranibizumab

E-Cigarettes using synthetic nicotine come under FDA oversight

USFDA authorises first C-19 diagnostic test using breath samples

Govt wants to ease compliance burden on Pharma Industry

FDA Maharashtra issues show cause notices to 95 Pharma units

NPPA fixes retail price of 23 formulations: April 2022

FDA warns websites illegally selling Amphetamine and Dextroamphetamine

16 Pharma units get ‘stop production orders’ for norm violations

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news