| PITTSBURGH – 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 Strength | Size | Batch# | Expiry | 49502-196-75 | Semglee® (insulin glargine injection), 100 units/mL (U-100) | 3mL Prefilled Pen | BF20003118 | August 2022 | Risk 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. | | | |
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