Viatris Recalls One Batch Of Diabetes Treatment Semglee Citing Missing Label Risks

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Viatris Inc's VTRS Mylan will pull one batch of non-interchangeable Semglee, also known as insulin glargine injection. 

  • The Company cited the risk of the label is missing on some prefilled pens contained inside labeled cartons of the drug.
  • The recall doesn't cover Viatris' recently launched interchangeable Semglee biosimilars, which come in branded and unbranded formats.
  • The lot in question was produced by Biocon and distributed by Mylan in the U.S. between May 11, 2021, and Nov. 11, 2021. 
  • According to the release, the batch, which contains cartons of five 3-ml prefilled Semglee pens, was due to expire in August 2022.
  • Viatris did not say how many five-pen cartons were in the lot. 
  • The labeling glitch could pose problems for patients who use both long- and short-acting insulin to manage their diabetes, Viatris warned. 
  • Patients could accidentally take the wrong insulin, which could hamper glycemic control, resulting in serious health risks.
  • As of Wednesday, Viatris had not received any safety reports linked to the recall.
  • Price Action: VTRS shares are up 0.28% at $14.76 during the market session on the last check Thursday.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsDiabetes
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