text: Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the BatchCompany Announcement Date: January 18, 2022FDA Publish Date: January 19, 2022Product Type: DrugsReason for Announcement: Missing LabelCompany Name: Mylan Pharmaceutical Inc.Brand Name: SemgleeProduct Description: Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pensCompany AnnouncementPITTSBURGH - Jan. 18, 2022 - Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labelled carton for this particular batch.This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11, 2021 and November 11, 2021. The recalled lot is as follows:NDC #Name and StrengthSizeBatch#Expiry49502-196-75Semglee (insulin glargine injection),100 units/mL (U-100)3mL Prefilled PenBF20003118August 2022Risk Statement: A missing label on Semglee (insulin glargine) prefilled pens, for patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), could lead to a mix-up of products/strengths, resulting in administration of the wrong insulin. Administration of the wrong insulin could result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, the company has not received any reports of adverse events related to this recall.This recall does not pertain to the recently launched interchangeable biosimilars, Semglee (insulin glargine-yfgn) injection, a branded product, or Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product.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 and is packaged in prefilled pens in cartons of five (5) pens. The recalled product can be identified by prefilled pens missing a white label with the product name and dosage information affixed around the pen.