United States
Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pens. This batch is being recalled due to the potential for the label to be missing on some pens. This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between April 4, 2022 and May 5, 2022. To date, no adverse events related to this recall have been received for this product.
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 pens 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.
This recall pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens and does not impact the branded interchangeable biosimilar Semglee® (insulin glargine-yfgn) injection pens. This 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 product is packaged in a 3 mL prefilled pen which is then packaged in cartons of five pens. The product information, batch number and expiry date information are present on the carton.
The recalled batch information is as follows:
NDC #: 49502-394-75
Name and Strength: Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100)
Size: 3 mL Prefilled Pen
Batch #: BF21002895
Expiry: Aug 2023
The company has initiated the recall of batch BF21002895 by notifying its distributors and retailers by letter and arranging for return of all recalled products. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others and it enables better surveillance.
Company name: Mylan Pharmaceuticals Inc.
Brand name: Mylan Pharmaceuticals Inc.
Product recalled: Insulin Glargine (Insulin glargine-yfgn) Injection Pens
Reason of the recall: Potential for the label to be missing on some pens.
FDA Recall date: July 06, 2022
Source:
www.fda.gov
