RELATED: If You Use This Common Medication, Call Your Doctor Immediately, FDA Warns Mylan Pharmaceuticals, a Viatris company, is voluntarily recalling a single batch of its non-interchangeable Semglee insulin glargine injection pens. The items in question are 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labeled carton of five.ae0fcc31ae342fd3a1346ebb1f342fcb This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11, 2021 and Nov. 11, 2021. The recalled lot is batch number BF20003118 with an expiration date of Aug. 2022. The company announced the recall on Jan. 18 and the U.S. Food & Drug Administration (FDA) published it on Jan. 19. RELATED: If You Use This Medication, Stop Immediately, FDA Says. The product is a long-acting human insulin analog prescribed to improve glycemic control in adults and kids with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. RELATED: If You Have This OTC Medication, Stop Using It Immediately, FDA Warns. The company says the product is being recalled due to the potential for the label to be missing on some prefilled pens within a labeled carton; prefilled pens are missing a white label with the product name and dosage information to correctly identify them. The recall only concerns this particular single batch. According to the risk statement published by the FDA, the labeling issue could result in a “mix-up of products/strengths, resulting in administration of the wrong insulin” for patients receiving treatment with more than one type of insulin (such as both short and long-acting insulin). This could lead to either high or low blood sugar levels, which could result in serious complications. Fortunately, the company has not received any reports of health issues related to this recall so far. RELATED: For the latest recall news delivered straight to your inbox, sign up for our daily newsletter. The company has started the recall of batch BF20003118 and notified its distributors and retailers to pull the affected drugs from circulation to arrange for their return. If you have one of the affected products at home, you’re asked to contact Stericycle at 888-843-0255 to request the documentation packet to return the product. If you have questions, contact Viatris Customer Relations at 800-796-9526 or [email protected], Monday through Friday from 8 a.m. through 5 p.m. EST. You should contact your doctor if you’ve experienced any problems that may be related to this drug. RELATED: If You Use This Medication, Stop Immediately, FDA Says.
