Mylan Recalls Semglee Prefilled Pens

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The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.

Mylan Pharmaceuticals, a Viatris company, announced on Jan. 18, 2022, that it is voluntarily recalling one batch of non-interchangeable Semglee (insulin glargine injection), 100 units/mL (U-100), 3mL prefilled pens because of a possible missing label in the batch. The recalled batch was manufactured by Biocon Sdn Bhd and distributed by Mylan Specialty L.P. in the United States between May 11, 2021 and Nov. 11, 2021. The recall does not apply to interchangeable biosimilars, Semglee (insulin glargine-yfgn) injection, a branded product, or Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product.

Non-interchangeable Semglee (insulin glargine injection) is a long-acting human insulin analog used to improve glycemic control in patients with type 1 and type 2 diabetes mellitus. According to the company, a missing label could cause a mix-up of products/strengths and lead to administration of the incorrect insulin.

There have been no reports of adverse events related to the recall as of the date of the recall notice. Adverse events may be reported to FDA via the agency’s MedWatch Adverse Event Reporting program.


Source: FDA