Safety Report: Mylan Insulin Glargine Injection - recalled due to missing label, USA

United States

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 # 49502-393-80
Name and Strength: Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100)
Size: 10 mL vial
Batch# BF21002800
Expiry: Aug 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.

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

Company name: Mylan Pharmaceuticals, Inc. a Viatris Company
Brand name: Mylan
Product recalled: Insulin Glargine (Insulin glargine-yfgn) Injection
Reason of the recall: Label may be missing on some vials
FDA Recall date: April 12, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-nationwide-recall-one-batch-insulin