Industry

Drug recall: Mylan Pharma recalled Insulin Glargine inj due to this reason

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

January 25, 2022

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Last Updated on January 3, 2024 by The Health Master

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 labeled 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:

Click for more on Mylan Pharma

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-acting and long-acting insulin), could lead to a mix-up of products/strengths, resulting in the administration of the wrong insulin.

Administration of the wrong insulin could result in less optimal glycemic control (either high or low blood sugar), which could result in serious complications.

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

Click for more on USFDA

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

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 and is packaged in prefilled pens in cartons of five (5) pens.

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

The company has initiated the recall of batch BF20003118 and notified its distributors and retailers by letter and is arranging for return of all recalled products.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. (USFDA).

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