Viatris' Mylan Recalls One Batch Of Insulin Glargine Due To Missing Label

Mylan Pharmaceuticals Inc, a Viatris Inc VTRS 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. 

• The batch is being recalled due to the potential for the label to be missing on some vials. 
• Biocon Sdn manufactured this batch. Bhd. and was distributed by Mylan Specialty L.P. in the U.S. between December 9, 2021, and March 4, 2022. 
• The company said that for patients receiving treatment with more than one type of insulin, a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, resulting in less optimal glycemic control (either high or low blood sugar).
• No adverse events related to this recall have been received for this product.
• The 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 adults with type 2 diabetes mellitus.
• Price Action: VTRS shares are up 0.75% at $10.75 during the premarket session on the last check Wednesday.