Mylan is voluntarily recalling 1 batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100) due to the possibility of a missing label on some of the vials.
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 vial.
The recalled lot of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100); NDC #49502-393-80; Batch # BF21002800; Expiration Date August 2023, was distributed to wholesalers and retailers in the United States between December 9, 2021 and March 4, 2022.
While the Company has yet to be alerted to adverse events related to this issue, a missing label on the vial could potentially lead to a mix-up of products and strengths for patients receiving treatment with more than one type of insulin.
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]
Mylan Pharmaceuticals Inc., a Viatris Company, conducting voluntary nationwide recall of one batch of Insulin Glargine (insulin glargine-yfgn) injection, 100 units/mL (U-100), due to the potential for a missing label in the batch. News release. Mylan Pharmaceuticals Inc. April 12, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-nationwide-recall-one-batch-insulin