Some vials have been found to be missing a label.
Mylan Pharmaceuticals, a Viatris company, is 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 product being recalled 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 but the product information, batch number and expiration date are on the carton.
This batch was manufactured by Biocon Sdn. Bhd. and was distributed in the United State by Mylan Specialty between December 9, 2021, and March 4, 2022.
The impacted product has an expiration date of August 2023, with an NDC number of 49502-393-80.
Mylan notes that a missing label could lead to a mix-up of products/strengths, which may result in less optimal glycemic control. To date, no adverse events related to this recall have been received for this product.