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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
However, the company has not received any reports of adverse events related to the recall to date.<\/p>\n
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.<\/p>\n
The recalled product can be identified by prefilled pens missing a white label with the product name and dosage information affixed around the pen.<\/p>\n
Wholesalers and retailers are asked to discontinue distribution of the affected batch, while consumers are asked to return the product to Stericycle. <\/p>\n