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April 14, 2022 – Due to the potential for missing labels, Mylan has recalled batch BF21002800 of its Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL vial inside a carton.
- There is no impact to members through Benecard Central fill.
- Insulin glargine-yfgn is indicated to improve glycemic control in adults who have type 1 or type 2 diabetes mellitus and in pediatric patients who have type 1 diabetes mellitus. A missing label could cause a mix-up in which insulin is being used, which could cause high or low blood sugar and potentially serious complications. As of the recall date, Mylan has received no reports of related adverse events.
- Mylan asks consumers to contact their healthcare provider if they have experienced any problems that may be due to using the affected product. For returns of unlabeled insulin glargine-yfgn, consumers should contact Stericycle at 1-888-912-7084. Questions about the recall can be directed to Viatris Customer Relations at 1-800-796-9526 or customer.service@viatris.com.
- The recall does not apply to Semglee® (insulin glargine-yfgn) injection, the branded interchangeable biosimilar for Sanofi’s Lantus® (insulin glargine) injection. It applies only to the unbranded interchangeable biosimilar insulin glargine-yfgn.
- A full copy of the recall notice is available on the FDA’s website.