Blog Big Molecule Watch July 08, 2022

Mylan Voluntarily Recalls Additional Batch of Biosimilar Insulin Glargine Pens Due to Potential Missing Labels

On July 5, Mylan announced another voluntary recall of a batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens “due to the potential for the label to be missing on some pens.”  The recalled product is not the branded SEMGLEE® pen, but rather the unbranded interchangeable Insulin Glargine-yfgn pens.  Mylan reports that no adverse events related to the recall have been recorded, and the recall was initiated due to the risk that patients receiving treatment with more than one type of insulin may mix up the products which could lead to complications.  The recalled batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the United States.

This is Mylan’s third voluntary recall of insulin glargine this year, caused by the potential for the labels to be missing on some prefilled pens.  On January 18, Mylan recalled a batch of its non-interchangeable SEMGLEE® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens.  On April 12, Mylan recalled one batch of its unbranded Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100).

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