Insulin has been recalled for a problem that could result in ‘serious complications’
Mylan Pharmaceuticals is recalling one batch of Insulin Glargine Injection 100 units/ml. Here’s what you need to know:
What insulin is recalled?
Batch No. BF21002800 of Insulin Glargine Injection, packaged in 10 ml vials inside a carton, NDC No. 49502-393-80, expiration August 2023 is recalled.
It was distributed between Dec. 9 and March 4. Mylan’s FDA-posted recall notice points out this isn’t the “branded, interchangeable biosimilar, Semglee,” but rather its unbranded cousin.
It’s “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 recall notice says.
What’s the potential problem with this insulin?
As Mylan’s risk statement says, “For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine vials 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.”
What should you do if you have this insulin?
Wholesalers should send a Microsoft Excel file list of customers, retail included, mylan5889@sedgwick.com, in five business days. Sedgwick (Stericycle) will notify retail customers that they received the affected batch.
Retailers should quarantine and stop selling the batch. Consumers should reach out to Stericycle at 888-912-7084 for a packet to return product to Stericycle.
If this or any other drug or drug dispenser causes a medical problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088. Then, notify the manufacturer.
This story was originally published April 13, 2022 at 1:07 PM with the headline "Insulin has been recalled for a problem that could result in ‘serious complications’."
