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Benzinga
Benzinga
Technology
Vandana Singh

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

Mylan Pharmaceuticals Inc, a Viatris Inc (NASDAQ: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.
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