Class I Recall for Diabetes Injection Pens

Mylan Pharmaceuticals Inc, a Viatris company, is recalling a single lot of prefilled pens containing insulin glargine injection because some of the pens may be missing labels.

According to the August 3, 2022, US Food and Drug Administration (FDA) Enforcement Report, the recall has been designated Class I by the FDA. The classification warns use of the affected product could cause serious adverse health consequences or death.

“For patients receiving treatment with more than one type of insulin (eg, 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), which could result in serious complications,” Mylan Pharmaceuticals stated in a July 5, 2022, company announcement.

The recall affects insulin glargine (insulin glargine-yfgn) injection, 100 units/mL (U-100), 3-mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), from lot BF21002895 (Exp. 8/23). The lot was manufactured by Biocon Sdn. Bhd. and distributed throughout the United States by Mylan Specialty LP between April 4, 2022, and May 5, 2022.

The recall affects only unbranded interchangeable biosimilar insulin glargine-yfgn pens and not branded interchangeable biosimilar Semglee (insulin glargine-yfgn) injection pens, the company pointed out.

Mylan Pharmaceuticals voluntarily initiated the recall July 5, 2022. On July 26, 2022, the FDA designated the recall Class I.

Insulin glargine injection is a long-acting human insulin analog available with a prescription to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.