Drug Safety Alerts

Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL Prefilled Pens Expanded Consumer-Level Recall

7/5/2022

On July 5, 2022, Mylan Pharmaceuticals Inc., a Viatris Company, issued a consumer-level recall of one lot of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens NDC # 49502-0394-75. This recall was issued due to the potential for the label to be missing on some pens.

This could be a health hazard or safety risk to patients using product affected by this recall.

This recall affects lot number BF21002895 exp. 08/2023.

For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine pens could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) and serious complications. According to Mylan, to date, no adverse events related to this recall have been received for this product.

This recall pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens and does not impact the branded Semglee® injection pens.

This 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 product is packaged in a 3 mL prefilled pen which is then packaged in cartons of five pens. The product information, batch number and expiry date information are present on the carton.

This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between April 4, 2022 and May 5, 2022.

CVS Caremark Response:

Please note: This product is not carried the CVS Caremark® Mail Service Pharmacies. CVS Specialty is sending letters to members who received this product through CVS Specialty Pharmacy and their physicians.

For more information about this recall, please call Viatris Customer Relations by phone at 1‑800-796-9526, Monday through Friday, 8:00 am to 5:00 pm (CT) or e-mail customer.service@viatris.com or visit https://newsroom.viatris.com.You may also call the United States Food and Drug Administration (FDA) at 1-888 INFO FDA (1 888 463 6332) or visit https://www.fda.gov.