Mylan Recalls Certain Semglee(insulin Glargine) Prefilled Pens

mylan jan20 lt

Mylan Pharmaceuticals Inc., affiliated to healthcare company Viatris Inc., is recalling one batch of its non-interchangeable Semglee (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens due to the potential for a missing label, the U.S. Food and Drug Administration said.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

The recall involves 3mL Prefilled Pen under batch BF20003118 and expiry date of August 2022. The Semglee prefilled pens are packaged in a labelled carton of five pens.

The affected batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11 and November 11, 2021.

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.

According to the agency, a missing label on Semglee(insulin glargine) prefilled pens could lead to a mix-up of products/strengths for patients receiving treatment with more than one type of insulin, e.g., both short and long-acting insulin. The possibility to administer the wrong insulin could result in less optimal glycemic control resulting in serious complications.

However, the company has not received any reports of adverse events related to the recall to date.

The recall does not affect the recently launched interchangeable biosimilars, Semglee (insulin glargine-yfgn) injection, a branded product, or Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product.

The recalled product can be identified by prefilled pens missing a white label with the product name and dosage information affixed around the pen.

Wholesalers and retailers are asked to discontinue distribution of the affected batch, while consumers are asked to return the product to Stericycle.

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