Mylan Pharmaceuticals is voluntarily recalling 1 lot of its noninterchangeable Semglee® (insulin glargine injection) 100 units/mL (U-100), 3mL prefilled pens due to the potential for a missing label.

The recalled lot includes NDC # 49502-196-75; Batch # BF20003118; Expiration Date August 2022. It was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty LP in the US between May 11, 2021 and November 11, 2021. 

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

A missing label on Semglee prefilled pens may lead to a mix-up of products or strengths resulting in incorrect administration of insulin. To date, the Company has not received reports of adverse events related to this recall.

According to the Company, “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.”

Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.

For more information regarding this recall contact Viatris Customer Relations at (800) 796-9526 or by email at [email protected]

Reference

Mylan Pharmaceuticals Inc., a Viatris Company, conducting voluntary recall of one batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL prefilled pens, due to the potential for a missing label in the batch. News release. Mylan Pharmaceuticals Inc. Accessed January 20, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin