Mylan Pharmaceuticals has voluntarily recalled 1 batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3mL prefilled pens due to the potential for missing labels on some pens.
Insulin glargine 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 recalled product does not pertain to the branded interchangeable biosimilar, Semglee® (insulin glargine-yfgn), but to the unbranded interchangeable biosimilar insulin glargine-yfgn pens.
The recalled lot of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100); NDC #49502-394-75; Batch # BF21002895; Expiration Date August 2023, was distributed to wholesalers and retailers in the US between April 4, 2022 and May 5, 2022.
According to the Company, a missing label on the pens could potentially lead to a mix-up of products and strengths for patients receiving treatment with more than one type of insulin. To date, the Company has not received any adverse events related to this recall.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
Mylan Pharmaceuticals Inc., a Viatris Company, issues voluntary nationwide recall of one batch of Insulin Glargine (Insulin glargine-yfgn) Injection pens, 100 units/mL (U-100), due to the potential of missing labels on some pens. News release. Mylan Pharmaceuticals Inc. Accessed July 6, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-issues-voluntary-nationwide-recall-one-batch-insulin
This article originally appeared on MPR